Probiotic and Gastrointestinal Symptoms Due to Menstruation in Healthy Women

NCT04457401 | Completed

• 1 other identifier: IRB201901746
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastrointestinal function

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain

  The primary outcome is the change (average of the first 3 days of the second menstrual cycle during the study when on the intervention minus the average of the first 3 days of the first menstrual cycle during the study prior to initiating the intervention) in the daily Visual Analog Score for abdominal pain between women on the probiotic versus the placebo interventions. The visual analog scale is scored between 0 (not pain at all) - 100 (worst pain imaginable). A higher score is less desirable. While we anticipate that a menstrual cycle should last 28 days, there may be variability in this number due to variability in the length of each participant's menstrual cycle.

  28 days

Secondary Outcomes (3)

• Menstrual Symptom Questionnaire

  28 days

• Stool consistency

  Each day up to 9 weeks

• Stool frequency

  Each day up to 9 weeks

Other Outcomes (4)

• Digestive Health

  Every 7 days up to 9 weeks

• Quality of Life Related to Digestive Health

  Every 7 days up to 9 weeks

• Fecal microbial diversity

  Every 7 days up to 9 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Participant must menstruate regularly and consume an oral contraceptive
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a healthy female between the ages of 18 and 35 years who has regular menstrual cycles (i.e., every 24 to 33 days),
• 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,
• Be on an combination oral contraceptive,
• Willing and able to consume a probiotic or placebo supplement for approximately 8 weeks,
• Willing and able to complete daily and weekly questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided.),
• Willing to discontinue consumption of fermented foods or foods with live active cultures two weeks prior to beginning the study and throughout the study (This would include kefir, kombucha, yogurts with live, active cultures, etc.),
• Willing to discontinue consumption of fiber supplements (This would include Metamucil, Benefiber, or other products with added fiber supplement.),
• Willing to complete a pregnancy test before consuming the study supplement,
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits,
• Able to provide informed consent,
• Willing to provide a stool and vaginal sample ten times during the study (subgroup),
• Typically have one stool per day (subgroup).

You may not qualify if:

• Women who have a birth control implant, vaginal ring, shot, or patch or intrauterine device,
• Women who are lactating, attempting to become pregnant, know that they are pregnant, or test positive on a pregnancy test,
• Women who have consumed probiotic supplements in the last month,
• Currently being treated for any physician-diagnosed diseases or conditions,
• Women who have been diagnosed with any gynecological diseases of conditions (fibroma, endometriosis, etc),
• Women who have pain that is caused by a disorder in the woman's reproductive organs. This would include a physician diagnosis such as endometriosis, adenomyosis, uterine fibroma, or a pelvic infection,
• Allergy to milk, soy, or yeast,
• Use of another investigational product within 3 months of the screening visit,
• Use of any antibiotic drug within 1 month of screening.

Sponsors & Collaborators

• University of Florida: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611-0370, United States

Location

Related Publications (1)

• Judkins TC, Oula ML, Sims SM, Langkamp-Henken B. The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol. Trials. 2022 Jun 10;23(1):481. doi: 10.1186/s13063-022-06410-w.

  PMID: 35689274 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bobbi Langkamp-Henken, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigators, and anyone else directly involved with the study will remain blinded for its entirety.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled parallel study in which participants receive one of the study supplements (probiotic or placebo) for an 8-week intervention.

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: July 7, 2020
• Study Start: December 1, 2020
• Primary Completion: December 2, 2021
• Study Completion: June 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)