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Preventing Preterm Birth With Probiotics

NCT02692820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2017-09-20

No results posted yet for this study

Summary

Babies born preterm (before completing 37 weeks in the womb) are at increased risk of long-term disability and death. The investigators do not fully understand the cause(s) of preterm birth but it occurs more frequently when the normal, healthy bacteria (called Lactobacilli) in a woman's birth canal are replaced with unhealthy bacteria. Previous attempts to get rid of the unhealthy bacteria with antibiotics have not shown to affect the risk of preterm birth. The reason for this may be that what is required is the replacement of Lactobacilli in the birth canal. This can be done by asking women to take capsules containing lactobacilli once daily. To study whether oral Lactobacilli capsules compared with dummy capsules can reduce the risk of preterm birth, a large study involving approximately 10,000 women would be required. But the investigators do not know whether women would agree to take part in and complete such a study, and this is what the investigators wish to study in the small, initial study described here. The results of this study will show whether probiotics produce the desired biological effects on vaginal bacteria, and whether it would be feasible to perform the larger, definitive study of their effectiveness in prevention of preterm birth.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

The probiotic capsule contains the two probiotics Lactobacillus rhamnosus GR-1 (GR-1) and Lactobacillus reuteri RC-14 (RC-14). The product contains freeze-dried bacteria and excipients in a gelatin capsule;

OTHER

Placebo Comparator

The placebo contains excipients alone in a gelatin capsule

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Khalid S Khan, Phd · Queen Mary University of London

  • Rehan Khan, MD · Barts Health NHS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692820 on ClinicalTrials.gov