scholarly journals Use of Fecal transplantation with a novel diet for mild to moderate active ulcerative colitis: The CRAFT UC randomized controlled trial

2021 ◽  
Author(s):  
Chen Sarbagili Shabat ◽  
Franco Scaldaferri ◽  
Eran Zittan ◽  
Ayal Hirsch ◽  
Maria Chiara Mentella ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mucosal Healing ◽  
Fecal Transplantation ◽  
Randomized Controlled ◽  
Single Donor ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background We evaluated whether integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission rate in refractory ulcerative colitis (UC). Methods This was a blinded randomized controlled trial in adults with active UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and ≤ 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on day 1and rectal enemas on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet (UCED) for the patients. Group 3 received the UCED alone. The primary endpoint was week 8 clinical steroid free remission, defined as SCCAI <3. Results Sixty two of 96 planned patients were enrolled. Remission week 8 Group 1 was 2/17 (11.8%), Group 2 4/19 (21.1%), Group 3 6/15 (40%) (NS). Endoscopic remission was Group 1 2/17 (12%), Group 2 3/19 (16%), Group 3 4/15 (27%) (Group 1 vs.3 p=0.38). Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 FT patients (p=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group 1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (Group 2 vs.3, p=0.35). Conclusions UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.

scholarly journals OP01 Comparison of fecal transplantation, fecal transplantation with the novel UC diet or the UC diet alone for Refractory Mild to Moderate Active Ulcerative Colitis: The CRAFT UC randomized controlled trial

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S001-S001
Author(s):  
A Levine ◽  
F Scaldaferri ◽  
C Sarbagili Shabat ◽  
E Zittan ◽  
A Hirsch ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Trial ◽  
Mucosal Healing ◽  
Independent Effect ◽  
Fecal Transplantation ◽  
Randomized Controlled ◽  
Single Donor ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background We evaluated if integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission in refractory ulcerative colitis (UC) or have an independent effect on remission. We developed a novel diet specifically designed for the dysbiosis of UC and to decrease factors that impair goblet cells or mucous production. Methods This was a blinded randomized controlled pilot trial in adults with UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and < 11 and endoscopic Mayo score 2–3, refractory to medication. Group 1 received free diet and standard FT by colonoscopy on day 1and rectal enemas from a single donor on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a diet (UC Diet- UCD) for the patients after FT. Group 3 received the UC Diet alone without FT. Patients underwent a repeat endoscopy at week 8. The primary endpoint was clinical steroid free remission, defined as SCCAI <3, at week 8. Results Fifty-one of the 96 planned patients were enrolled. The mean age was 40.4 ±12.5 years, 28/51(54.9%) had failed a biologic, 15/40 (29.4%) were on steroids at enrolment. Remission week 8 in Group 1 was 2/17(11.8%), Group 2 was 4/19 (21.1%), and 6/15 (40%) Group 3 (NS). Endoscopic remission was present in Group 1: 2/17(12%), Group 2: 3/19(16%) and 4/15 (27%) Group 3. Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 patients receiving FT (P=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (NS). The study was stopped for futility by a safety monitoring board. Conclusion Fecal transplantation was not effective in this UC cohort. A UC Diet alone appeared to achieve higher clinical remission (40%) and mucosal healing than single donor FT with or without diet in mild to moderate UC failing medical therapy. This diet should be investigated further in a RCT specifically designed for the UCD. This study was supported by an ECCO Pioneer grant

Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24)

2021 ◽  
Vol 103-B (10) ◽  
pp. 1595-1603
Author(s):  
Paul Magill ◽  
Janet C. Hill ◽  
Leeann Bryce ◽  
Una Martin ◽  
Al Dorman ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
History Of ◽  
Total Knee ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.

A Randomized, Controlled Trial of Chlorhexidine-Soaked Cloths to Reduce Methicillin-Resistant and Methicillin-SusceptibleStaphylococcus aureusCarriage Prevalence in an Urban Jail

2014 ◽  
Vol 35 (12) ◽  
pp. 1466-1473 ◽  
Author(s):  
Michael Z. David ◽  
Jane D. Siegel ◽  
Janet Henderson ◽  
Greg Leos ◽  
Kaming Lo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Absolute Risk Reduction ◽  
Methicillin Resistant ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective.To assess an intervention to limit community-associated methicillin-resistantStaphylococcus aureus(MRSA) dissemination.Design.Randomized, controlled trial.Setting.County Jail, Dallas, Texas.Participants.A total of 4,196 detainees in 68 detention tanks.Methods.Tanks were randomly assigned to 1 of 3 groups: in group 1, detainees received cloths that contained chlorhexidine gluconate (CHG) to clean their entire skin surface 3 times per week for 6 months; group 2 received identical cloths containing only water; and group 3 received no skin treatment. During the study, all newly arrived detainees were invited to enroll. Nares and hand cultures were obtained at baseline and from all current enrollees at 2 and 6 months.Results.At baseline,S. aureuswas isolated from 41.2% and MRSA from 8.0% (nares and/or hand) of 947 enrollees. The average participation rate was 47%. At 6 months, MRSA carriage was 10.0% in group 3 and 8.7% in group 1 tanks (estimated absolute risk reduction [95% confidence interval (CI)], 1.4% [−4.8% to 7.1%];P= .655). At 6 months, carriage of anyS. aureuswas 51.1% in group 3, 40.7% in group 1 (absolute risk reduction [95% CI], 10.4% [0.01%–20.1%];P= .047), and 42.8% (absolute risk reduction [95% CI], 8.3% [−1.4% to 18.0%];P= .099) in group 2.Conclusions.Skin cleaning with CHG for 6 months in detainees, compared with no intervention, significantly decreased carriage ofS. aureus, and use of water cloths produced a nonsignificant but similar decrease. A nonsignificant decrease in MRSA carriage was found with CHG cloth use.Trial registration.ClinicalTrials.gov identifier NCT00785200.

scholarly journals Randomized controlled trial of three oxytocic regimens to prevent primary postpartum haemorrhage at caesarean section

Mediscope ◽  
2017 ◽  
Vol 4 (2) ◽  
pp. 5-11
Author(s):  
AJ Peea ◽  
F Begum ◽  
E Saha
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Caesarean Section ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

The objective of this present study was to compare the efficacy of three oxytocic regimens to prevent primary postpartum haemorrhage (PPH) at caesarean section. A randomized controlled trial including 90 patients who underwent caesarean section were selected according to inclusion and exclusion criteria assigned randomly into three groups (30 patients in each group) was conducted. Group 1 and group 2 were exposure groups and group 3 was control group. All patients were given 10 units intravenous (IV) bolus oxytocin immediately after delivery of baby. Group 1 was given additional 20 units oxytocin in each 1000 ml fluid for 24 hours. Group 2 received additional 1000 microgram misoprostol per rectal. Group 3 did not receive any additional oxytocic drug. Background characteristics of all the three groups were similar. It was observed that 501-1000 ml blood loss was found among 25 (83.3%) cases in group 1, 27 (90.0%) in group 2 and 27 (90.0%) in group 3. The mean (SD) amount of blood loss was found 733 (190) ml in group 1792 (187) ml in group 2 and 818 (14) ml in group 3. Occurrence of PPH and blood transfusion needed among 1 (3.3%) in group 1, 2 (6.7%) in group 2 and 3 (10.0%) in group 3. Side effects occurred in 7 (23.3%) patients of group 1, 18 (60.0%) in group 2, and 6 (20.0%) in group 3. Shivering was found among 4 (13.3%) in group 1, 10 (33.3%) in group 2 and 3 (10%) in group 3. Vomiting was found among 2 (6.7%) in group 1, 4 (13.3%) in group 2, and 2 (6.7%) in group 3. Pyrexia was 1 (3.3%) in group 1, 4 (13.3%) in group 2 and 1 (3.3%) in group 3. Side effects were more in the group where misoprostol was used. Except side effects there was no statistical difference of occurrence of different events among the three groups. Only bolus IV oxytocin appears to be as effective as oxytocin infusion in addition to bolus IV oxytocin or per rectal misoprostol in addition to bolus IV oxytocin to prevent primary PPH at caesarean section. But occurrence of transient side effects such as shivering, pyrexia and vomiting were noted more frequently with the use of misoprostol.Mediscope Vol. 4, No. 2: Jul 2017, Page 5-11

scholarly journals Comparison of intrauterine insemination and timed intercourse following controlled ovarian hyperstimulation in unexplained infertility: a randomized controlled trial

2019 ◽  
Vol 8 (3) ◽  
pp. 1035
Author(s):  
Sayanti Paul ◽  
Saumen Mandal ◽  
Arghya Pal ◽  
Sumit Ranjan Pramanik
Keyword(s):  
Randomized Controlled Trial ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Controlled Ovarian Hyperstimulation ◽  
Unexplained Infertility ◽  
Clinical Pregnancy ◽  
Ovarian Hyperstimulation ◽  
Randomized Controlled ◽  
Group 2 ◽  
Group 1

Background: Being a diagnosis of exclusion the treatment options of unexplained infertility are often empiric. There is significant dilemma regarding the superiority of one over another. Despite increasing use of intrauterine insemination (IUI) in adjunct to controlled ovarian hyperstimulation (COH) there is scarcity of randomized controlled trials (RCT) from developing countries. Objective was to compare IUI and timed intercourse (TI) in super ovulated cycles among couples with unexplained infertility over one year.Methods: In this prospective randomized controlled trial total 85 patients were randomly assigned into group 1 (COH with IUI, N= 44) and group 2 (COH with TI, N=41). Patients underwent COH using sequential Clomiphene Citrate and injection human menopausal gonadotrophin followed by IUI in group 1 and timed intercourse in group 2. Either protocol was repeated for three consecutive cycles. Finally, both groups were compared for clinical pregnancy rate, adverse effects and acceptability of the treatment process and outcome. Comparison was done by Student’s unpaired t test for continuous and 2-tailed chi square test for categorical variables.Results: Clinical pregnancy rates following COH/IUI and COH/TI were 13.64% and 19.51% respectively. There was observable difference in the acceptability of the outcome (38.64% in IUI and 56.09% in TI group). All the results including complications and side effect rates were statistically insignificant.Conclusions: Present study failed to show any improvement of pregnancy rates following addition of IUI over TI and it raised the probability that the outcome of the procedure may not be well accepted.

Effect of Chlorhexidine Cleansing of Umbilical Cord for Prevention of Infection

2018 ◽  
Vol 4 (2) ◽  
pp. 35-39
Author(s):  
Md Khairuzzaman ◽  
MA Mannan ◽  
Abdul Matin ◽  
Mst Monjuman Ara Sarker ◽  
Nihar Ranjan Sarker ◽  
...  
Keyword(s):  
Umbilical Cord ◽  
Controlled Trial ◽  
Care Group ◽  
Cord Care ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
To Receive ◽  
Level Hospital ◽  
Group 1

Background: Chlorhexidine cleansing of the cord can reduce neonatal mortality among newborns.Objective: The aim of study was to determine the effect of cord cleansing with chlorhexidine in reduction of umbilical infection among newborns in hospital settings.Methodology: This randomized controlled trial was carried out between April 2013 to July 2014 and 510 newborns were randomly assigned within a tertiary level hospital in Bangladesh to receive 1 of 3 cord care regimens single cord cleansing with 4% chlorhexidine(Group-1), multiple cord cleansing with 4% chlorhexidine (Group-2)  and clean and dry cord care (Group-3 : control).Results: The risk of umbilical cord infection (omphalitis) was significantly reduced in both the single (Relative risk [RR] 0.15 [95% CI] 0.008-0.93) and multiple chlorhexidine cleansing group (RR 0.37 [95% CI] 0.04- 0.99) compared to the dry cord care group.  The risk of omphalitis was not significantly different between multiple and single chlorhexidine cleansing group (RR 3.14 [0.13-76.54]). Conclusion: Chlorhexidine significantly reduce the risk of umbilical infection in both single and multiple cord cleansing neonates.Bangladesh Journal of Infectious Diseases 2017;4(2):35-39

Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis

2015 ◽  
Vol 149 (1) ◽  
pp. 110-118.e4 ◽  
Author(s):  
Noortje G. Rossen ◽  
Susana Fuentes ◽  
Mirjam J. van der Spek ◽  
Jan G. Tijssen ◽  
Jorn H.A. Hartman ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Fecal Transplantation ◽  
Randomized Controlled

scholarly journals Effects of Water Restriction and Supplementation on Cognitive Performances and Mood among Young Adults in Baoding, China: A Randomized Controlled Trial (RCT)

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3645
Author(s):  
Jianfen Zhang ◽  
Guansheng Ma ◽  
Songming Du ◽  
Shufang Liu ◽  
Na Zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hydration Status ◽  
Water Restriction ◽  
Operation Span ◽  
Randomized Controlled ◽  
Baseline Test ◽  
Group 2 ◽  
Water Supplementation ◽  
Group 1

The brain is approximately 75% water. Therefore, insufficient water intake may affect the cognitive performance of humans. The present study aimed to investigate the effects of water restriction and supplementation on cognitive performances and mood, and the optimum amount of water to alleviate the detrimental effects of dehydration, among young adults. A randomized controlled trial was conducted with 76 young, healthy adults aged 18–23 years old from Baoding, China. After fasting overnight for 12 h, at 8:00 a.m. of day 2, the osmolality of the first morning urine and blood, cognitive performance, and mood were measured as a baseline test. After water restriction for 24 h, at 8:00 a.m. of day 3, the same indexes were measured as a dehydration test. Participants were randomly assigned into four groups: water supplementation group (WS group) 1, 2, or 3 (given 1000, 500, or 200 mL purified water), and the no water supplementation group (NW group). Furthermore, participants were instructed to drink all the water within 10 min. Ninety minutes later, the same measurements were performed as a rehydration test. Compared with the baseline test, participants were all in dehydration and their scores on the portrait memory test, vigor, and self-esteem decreased (34 vs. 27, p < 0.001; 11.8 vs. 9.2, p < 0.001; 7.8 vs. 6.4, p < 0.001). Fatigue and TMD (total mood disturbance) increased (3.6 vs. 4.8, p = 0.004; 95.7 vs. 101.8, p < 0.001) in the dehydration test. Significant interactions between time and volume were found in hydration status, fatigue, vigor, TMD, symbol search test, and operation span test (F = 6.302, p = 0.001; F = 3.118, p = 0.029; F = 2.849, p = 0.043; F = 2.859, p = 0.043; F = 3.463, p = 0.021) when comparing the rehydration and dehydration test. Furthermore, the hydration status was better in WS group 1 compared to WS group 2; the fatigue and TMD scores decreased, and the symbol search test and operation span test scores increased, only in WS group 1 and WS group 2 (p < 0.05). There was no significant difference between them (p > 0.05). Dehydration impaired episodic memory and mood. Water supplementation improved processing speed, working memory, and mood, and 1000 mL was the optimum volume.

scholarly journals A Randomized Controlled Trial of Curcuma longa and Boswellia serrata Extract in Osteoarthritis

2019 ◽  
pp. 51-56
Author(s):  
Rizaldy Taslim Pinzon ◽  
Rosa De Lima Renita Sanyasi ◽  
Esdras Ardi Pramudita ◽  
Septian Dewi Periska
Keyword(s):  
Randomized Controlled Trial ◽  
Curcuma Longa ◽  
Controlled Trial ◽  
Diclofenac Sodium ◽  
Therapeutic Interventions ◽  
Boswellia Serrata ◽  
Randomized Controlled ◽  
Drug Of Choice ◽  
Group 3 ◽  
Group 2

Background: Chronic pain is the major complaint in subjects with osteoarthritis (OA). Non-steroid anti-inflammatory drug (NSAID) is still the drug of choice in Indonesia to treat OA patients. The prolonged consumption of NSAID may lead to many adverse events (AE). Some previous studies showed the extract of Curcuma longa and Boswellia serrata is a promising potential as therapeutic interventions against OA. Objective: This study aimed to evaluate the effectiveness and safety of CB extract to relieve symptoms in patients with OA. Study Design: This was a randomized controlled trial (RCT) in OA patients. The treatment used in this trial were CB extract (350 mg of Curcuma longa and 150 mg Boswellia serrata) and NSAID (400 mg ibuprofen or 50 mg diclofenac sodium). Subjects were randomized to 3 different groups (Group 1: CB extract and NSAID; group 2: CB extract; group 3: NSAID). Each medication was taken two times per day for four weeks. Paracetamol tablet 500 mg gave to each subject as a rescue medication.

scholarly journals Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients with Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

2021 ◽  
pp. 484-494
Author(s):  
Hira Abbasi ◽  
Abhishek Lal ◽  
Ammara Shamim Jaffrani
Keyword(s):  
Randomized Controlled Trial ◽  
Calcium Hydroxide ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores ◽  
Post Operative Pain ◽  
Group 2 ◽  
Irreversible Pulpitis ◽  
Group 1

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design:  Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

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