Probiotics and Low-FODMAP diet tested for chronic pelvic pain relief
NCT ID NCT07149519
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at whether a special low-FODMAP diet and probiotics can reduce chronic pelvic pain in women who have both endometriosis and irritable bowel syndrome (IBS). Researchers will compare three groups: one getting the diet plus a placebo, one getting the diet plus probiotics, and one eating their usual diet. The goal is to see if these approaches improve pain and quality of life over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- probiotics (Lactobacillus spp) and low-FODMAP diet
- What this could lead to
- If it works, this could offer a simple, non-drug way to reduce pelvic pain and improve quality of life for women with both endometriosis and IBS.
- What could go wrong
- This is a small, early-stage trial with only 74 participants, so results may not apply to everyone. The diet and probiotics may not help all women, and the study does not test for long-term effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Women between 18 and 50 years of age who wish to participate in the clinical trial; 2. Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms; 3. Participating exclusively in this clinical trial during the study period; 4. Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP Exclusion Criteria: 1. Chronic, severe, or uncompensated clinical conditions, such as: malnutrition (BMI \<18); insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension; lung disease such as asthma or other chronic obstructive pulmonary disease; hematologic and liver diseases; advanced-stage chronic kidney disease (grades 3, 4, and 5); metabolic disorders; and immunosuppression; 2. Clinical conditions of the gastrointestinal tract that cause IBS-like symptoms, such as: inflammatory bowel disease (Chron's disease, ulcerative colitis), microscopic colitis, celiac disease, and lactose intolerance; 3. Endometriosis requiring surgical treatment during the study period; 4. Severe eating disorders, such as: bulimia, anorexia nervosa, and binge-eating disorder; 5. Chronic use of any medication with potential interaction with probiotics, the intestinal microbiota, or the natural progression of the disease in the last 6 months (such as probiotics, antibiotics, antifungals, antihistamines, digestive medications, or treatments for constipation or diarrhea); 6. Patients who already consume healthy foods or are on a restrictive diet more than four days a week, which may affect the evaluation results; 7. Patients whose stool protopastological examination is altered; 8. Inability to use oral medication; 9. Pregnancy or lactation; 10. History of alcohol or drug dependence; 11. Smoking in the last three years; 12. Inability to cooperate with investigators due to cognitive impairment or mental state.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Letícia Ferracini Lenharo Hayashi
RECRUITINGCatanduva, São Paulo, 15800-050, Brazil
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- Can AI learn to spot endometriosis and fibroids on ultrasound?