Irritable Bowel Syndrome (IBS) Clinical Trials

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Impact of Dietary Guidance and Probiotics in the Treatment of Chronic Pelvic Pain Secondary to Endometriosis and Irritable Bowel Syndrome in Women: A Randomized, Double-Blind Clinical Trial

Status: Recruiting

Location: See location...

Intervention Type: Dietary supplement

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities.

Eligibility

Participation Requirements

Sex: Female

Minimum Age: 15

Maximum Age: 50

Healthy Volunteers: f

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• Women between 18 and 50 years of age who wish to participate in the clinical trial;

• Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms;

• Participating exclusively in this clinical trial during the study period;

• Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP

Locations

Other Locations

Brazil

Letícia Ferracini Lenharo Hayashi

RECRUITING

Catanduva

Time Frame

Start Date: 2025-03-01

Estimated Completion Date: 2029-02-15

Participants

Target number of participants: 74

Treatments

Placebo_comparator: Arm 1: Specific dietary guidance associated with placebo.

Patients in this group will receive, within 24 hours of randomization, guidance on a low-FODMAP diet, which must be followed for 12 weeks (120 days), and placebo.

Experimental: Arm 2: Specific dietary guidance combined with probiotics.

Patients in this group will receive, within 24 hours of randomization, the same low-FODMAP diet guidance combined with probiotics (Lactobacillus and L. gasseri combinations) administered orally once daily for 12 weeks.

No_intervention: Arm 3: Control - exclusive habitual diet

Patients in this group will be instructed to maintain their usual diet and will be administered a placebo. After the 12-week period, if the active treatment group (Arm 1 and 2) has shown a satisfactory clinical response, we will offer specific dietary guidance and probiotics to the control group participants who did not show clinical improvement.

Related Therapeutic Areas

Endometriosis

Irritable Bowel Syndrome (IBS)

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