Effect of FODMAP Diet on Pain, Quality of Life, and Sexual Function in Women With Pelvic Endometriosis and Gastrointestinal Symptoms

NCT07590895 | Recruiting

• 1 other identifier: 3655_S_P
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to assess whether a dietary regimen based on the principles of the FODMAP diet, compared with the current treatment programme which does not include specific dietary recommendations, can improve pain symptoms in patients with symptomatic endometriosis and intestinal symptoms (i.e. bloating, nausea, constipation, diarrhoea and vomiting) attributable to irritable bowel syndrome, compared with a control group

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Change of pain related syntomps in patients with bowel symptoms

  The primary objective of the study is to evaluate whether a dietary regimen based on the principles of the FODMAP diet versus the current treatment program, which does not include specific dietary indications, can change algic symptoms in patients with symptomatic endometriosis and the presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, compared with a control group. The outcome will be measured trough Numerical Rating Scale (NRS) on dismenorrea, dyspareunia, non menstrual pelvic pain and dyschezia.

  6 months

Secondary Outcomes (1)

• Gastrointestinal syntomps, patient satisfaction, health-related quality of life, psychological conditions, patient's overall condition and anthropometric parameters

  6 months

Study Arms (2)

FODMAP diet group

EXPERIMENTAL

Patients randomized to the treatment arm were proposed to follow a FODMAP diet throughout the study period

Behavioral: FODMAP diet

Usual diet group

NO INTERVENTION

Interventions

FODMAP diet BEHAVIORAL

Diet low in oligosaccharides, disaccharides, monosaccharides and fermentable polyols

FODMAP diet group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years
• BMI between 18.5 and 24.9,
• Surgical, clinical or instrumental diagnosis of endometriosis
• Presence of bowel symptoms (i.e., bloating, nausea, constipation, diarrhea, and vomiting) referable to irritable bowel syndrome, on estro-progestin or progestin treatment or in the absence of hormonal treatment

You may not qualify if:

• Associated conditions that may cause pelvic pain independent of the presence of endometriosis (e.g., pelvic varices and salpingitis outcomes)
• chronic inflammatory bowel disease (Crohn's disease or ulcerative rectocolitis).
• patients with obstructive uropathy, subocclusive intestinal stenosis
• complex adnexal masses or typical endometriomas greater than 5 cm in diameter.
• women who are obese (BMI ≥ 30) or underweight (BMI \< 18)
• women on vegetarian-vegan dietary regimens,
• women with metabolic diseases that require specific dietary indications such as in the case of diabetes and celiac disease.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Giussy Barbara

CONTACT

+393471753089; giussy.barbara@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 15, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)