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

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FODMAP diet

    Behavioral

    Diet low in oligosaccharides, disaccharides, monosaccharides and fermentable polyols

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: FODMAP diet groupExperimental treatment 1 intervention
Group B: Usual diet groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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

1. Assessment of patient satisfaction during treatment, measured using a five-point Likert scale 2. Assessment of gastrointestinal symptoms (abdominal bloating, nausea, constipation, diarrhea, and vomiting) using a numerical rating scale (NRS, 0 to 10) 3. The impact on health-related quality of life assessed using the Short-Form Health Survey 12 (SF-12) 4. The impact on sexual function using the Female Sexual Function Index (FSFI) questionnaire 5. The impact on patients' psychological conditions using the HADS (Hospital Anxiety and Depression Scale) 6. The patient's overall condition using the Patients' Global Impression of Change (PGIC) scale, a seven-point scale (greatly improved, much improved, slightly improved, unchanged, slightly worsened, muc 7. Changes in anthropometric parameters through changes in BMI and impedance analysis of body composition

Time frame
6 months

Other outcomes

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