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Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women

NCT04457401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2024-06-28

No results posted yet for this study

Summary

In this double blind, parallel study, female participants who are on an oral contraceptive will consume either a probiotic or placebo supplement for approximately 8 weeks. Menstrual cramp and abdominal pain severity, as measured by the visual analog scale, will be assessed daily. A subgroup of participants will be asked to provide vaginal swab and stool samples to assess microbial communities.

Conditions

  • Menstrual Discomfort

Interventions

DIETARY_SUPPLEMENT

Probiotic

This probiotic is commercially available and contains Bifidobacterium (3 x 10\^9 colony forming units/capsule) as the active ingredient and potato starch, magnesium stearate and ascorbic acid as excipients.

DIETARY_SUPPLEMENT

Placebo

The placebo contains potato starch, magnesium stearate and ascorbic acid.

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Bobbi Langkamp-Henken, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-02
Completion
2024-06-01

Countries

  • United States

Study Locations

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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 NCT04457401 on ClinicalTrials.gov