Evaluation of Treatment Effect of Low FODMAP Diet in Treatment of IBS Patients

Taipei Veterans General Hospital

Status: Unknown

Conditions: Irritable Bowel Syndrome

Treatments: Behavioral: Low FODMAP diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05144204

2018-07-023B

Details and patient eligibility

About

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder, affecting 15% of the population. IBS is characterized by recurrent abdominal pain/discomfort without identifiable organic lesions. The pathophysiology of IBS can be multi factors which included immune activation/inflammatory reactions, visceral hypersensitivity, gastrointestinal dysmotility, changes in gut microflora, brain-gut dysfunction and food intolerance. Many short-chain carbohydrates can induce abdominal symptoms, and these carbohydrates were called, Fermentable, Oligosaccharides, Disaccharides and Monosaccharides and Polyols (FODMAPs). Around 50- 86% of the IBS patients will have a clinically meaningful response to the low-FODMAP diet. To evaluate the efficacy of low FODMAP diet. Experimental design: Health control and patients meeting the ROME III criteria for IBS will be enrolled in this study. The basic profiles, patient characteristics, intestinal microbiota profiles and MRI images will be obtained before and after low FODMAP diet intervention.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients are eligible for the study if all of the following criteria are met:

1. Patients with irritable bowel syndrome as per Rome IV diagnostic criteria Symptom characteristics of IBS according to Rome III and IV criteria
2. Patients must provide witnessed written informed consent prior to any study procedures being performed
3. Patients aged between 20-65 years
4. Male or female patients

Exclusion criteria

• Exclusion criteria including:

  1. Unable to provide or understand written informed consent.
  2. Pregnancy.
  3. Receiving antibiotics or narcotics within 90 days prior to enrollment.
  4. Receiving new prebiotics, probiotics within 90 days prior to enrollment.
  5. Current infection.
  6. History of inflammatory bowel disease.
  7. Thyroid disease.
  8. Major psychiatric disorders, including clinical anxiety or depression and previous use of anxiolytics and antidepressants.
  9. Previous stroke, intracerebral hemorrhage, or central nervous system diseases.
  10. Malignancy.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Irritable Bowel Syndrome Patients

Experimental group

Treatment:

Behavioral: Low FODMAP diet