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Probiotics for Menstrual Cramps

N/A

Waitlist Available

Led By Bobbi Langkamp-Henken, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing and able to consume a probiotic or placebo supplement for approximately 8 weeks

On the daily gastrointestinal symptom questionnaire for abdominal pain, participants must have a score of ≥ 3 for abdominal pain when thinking about their typical average score during first three days of menstruation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 7 days up to 9 weeks

Awards & highlights

Study Summary

This trial is testing whether taking a probiotic supplement can reduce the severity of menstrual cramps and abdominal pain in women who are on an oral contraceptive.

Who is the study for?

Healthy women aged 18-35 with regular menstrual cycles and on oral contraceptives can join this trial. They must experience significant abdominal pain during menstruation, not consume fermented foods or fiber supplements, and be willing to take daily health questionnaires. Exclusions include pregnancy, lactation, recent probiotic use or antibiotics, gynecological diseases, allergies to milk/soy/yeast, and other birth control methods.Check my eligibility

What is being tested?

The study tests if a probiotic supplement can reduce menstrual cramps compared to a placebo over an 8-week period. Participants will report their pain levels daily using a visual scale. Some will also provide vaginal swab and stool samples for microbial analysis.See study design

What are the potential side effects?

While the trial's focus is on probiotics that are generally considered safe, potential side effects may include digestive discomfort such as bloating or gas. Allergic reactions could occur in those sensitive to the supplement's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to take a probiotic or placebo for about 8 weeks.

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My typical abdominal pain score during the first three days of my period is 3 or higher.

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I am a healthy woman aged 18-35 with regular menstrual cycles.

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I am currently using a combination oral contraceptive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 7 days up to 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 7 days up to 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 7 days up to 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abdominal Pain

Secondary outcome measures

Menstrual Symptom Questionnaire

Stool consistency

Stool frequency

Other outcome measures

Digestive Health

Fecal microbial diversity

Quality of Life Related to Digestive Health

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProbioticExperimental Treatment1 Intervention

1 capsule daily for 8 weeks, containing 3 x 10^9 colony forming units/capsule of a Bifidobacterium strain

Group II: PlaceboPlacebo Group1 Intervention

1 capsule daily for 8 weeks containing the same carrier material and is similar in size, shape and taste to probiotic

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic

2013

Completed Phase 4

~3570

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,507 Total Patients Enrolled

Lallemand Health SolutionsIndustry Sponsor

39 Previous Clinical Trials

3,521 Total Patients Enrolled

Bobbi Langkamp-Henken, PhDPrincipal InvestigatorUniversity of Florida

4 Previous Clinical Trials

146 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04457401 — N/A

Menstrual Cramps Research Study Groups: Probiotic, Placebo

Menstrual Cramps Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04457401 — N/A

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements for participating in this research?

"This clinical trial seeks 191 participants between 18 and 35 years of age who experience menstrual discomfort. Qualified candidates must have regular mensuration cycles (between 24 to 33 days), be able to forgo fermented foods and fiber supplements, possess internet access for the duration of the study, and score 3 or higher in abdominal pain on a daily gastrointestinal symptom questionnaire. Additionally, volunteers will need to fill out multiple questionnaires regarding their dietary intake, general health and well-being while also attending all associated visits with this experiment."

Answered by AI

Does this investigation accept individuals aged 30 and over?

"As per the prerequisites for this clinical trial, individuals must be between 18-35 years old to qualify."

Answered by AI

Is it still possible to submit an application for this experiment?

"According to clinicaltrials.gov, the study is no longer looking for participants; it was initially posted on December 1st 2020 and last updated on July 6th 2022. That said, there are still four other trials that require candidates at this time."

Answered by AI