A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results

The Mediterranean diet (MD) has been inversely associated with lung cancer (LC) risk. Hereby we show the preliminary results of our prospective randomised controlled trial in inflammatory and nutritional status of LC patients after 3-month implementation of MD. In total, 30 patients with small-cell or non-small-cell LC (stages III–IV) were enrolled. They were randomly assigned either to Control group, receiving general nutritional guidelines, or the MD group, in which a personalised MD plan was provided. Medical and dietary history, anthropometrics, blood biomarkers, and circulating antioxidant vitamins were assessed. The main outcome was a significantly higher advanced lung cancer inflammation index (ALI) in patients of the control arm than those following MD (p = 0.003). In the MD group, platelets were significantly reduced at the study endpoint (p = 0.044). BMI and body fat mass remained unchanged in both arms, but serum glucose was significantly higher in control compared to MD group (p = 0.017). In conclusion, we showed for the first time that implementing a personalised MD for 3 months is promising to regulate prognostic biomarkers in advanced LC. The final results of our on-going trial will shed a light on the inflammatory, antioxidant and nutritional status of LC patients following MD.

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Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-013-1812-8 ◽

2013 ◽

Vol 133 (10) ◽

pp. 1407-1414 ◽

Cited By ~ 5

Author(s):

Joost W. Colaris ◽

Max Reijman ◽

Jan Hein Allema ◽

L. Ulas Biter ◽

Rolf M. Bloem ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Forearm Fractures ◽

Preliminary Results ◽

Fractures In Children ◽

Randomised Controlled

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OP0010 Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: Preliminary results of a phase 3 multicentre randomised controlled trial

European Journal of Cancer ◽

10.1016/j.ejca.2014.03.028 ◽

2014 ◽

Vol 50 ◽

pp. e3-e4 ◽

Cited By ~ 4

Author(s):

J. Ma ◽

N.-Y. Chen ◽

N. Zhang ◽

G.-Q. Hu ◽

Y. Sun ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Nasopharyngeal Carcinoma ◽

Induction Chemotherapy ◽

Concurrent Chemoradiotherapy ◽

Controlled Trial ◽

Phase 3 ◽

Preliminary Results ◽

Randomised Controlled

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Antibiotic prophylaxis to prevent post-abortal upper genital tract infection in women with bacterial vaginosis: randomised controlled trial

BJOG An International Journal of Obstetrics & Gynaecology ◽

10.1111/j.1471-0528.2001.00091.x ◽

2001 ◽

Vol 108 (4) ◽

pp. 396-402 ◽

Cited By ~ 2

Author(s):

Tessa Crowley ◽

Nicola Low ◽

Andrew Turner ◽

Ian Harvey ◽

Ken Bidgood ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Tract Infection ◽

Antibiotic Prophylaxis ◽

Bacterial Vaginosis ◽

Genital Tract ◽

Controlled Trial ◽

Genital Tract Infection ◽

Randomised Controlled ◽

Upper Genital Tract Infection

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THU0732-HPR Individual responder analysis of the effectiveness of manual therapy and exercise versus usual care in patients with chronic nonspecific neck pain: preliminary results of a randomised controlled trial

10.1136/annrheumdis-2018-eular.3693 ◽

2018 ◽

Author(s):

L.A. Domingues ◽

F.M. Pimentel-Santos ◽

E.B. Cruz ◽

J.C. Branco

Keyword(s):

Randomised Controlled Trial ◽

Neck Pain ◽

Usual Care ◽

Manual Therapy ◽

Controlled Trial ◽

Preliminary Results ◽

Responder Analysis ◽

Randomised Controlled

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Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

BMC Infectious Diseases ◽

10.1186/s12879-020-05563-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lenka A. Vodstrcil ◽

◽

Erica L. Plummer ◽

Michelle Doyle ◽

Christopher K. Fairley ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Bacterial Vaginosis ◽

Controlled Trial ◽

Male Partner ◽

Standard Of Care ◽

Trial Registration ◽

Current Standard ◽

Randomised Controlled ◽

Oral Metronidazole ◽

Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

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