(FODMAP) Diet on Improving Symptoms of Patients With Irritable Bowel Syndrome

NCT07299305 | Completed DMC

• 1 other identifier: Irritable bowel syndrome
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction, characterized by chronic abdominal pain and altered bowel habits. A low-FODMAP diet (LFD), which restricts specific types of fermentable carbohydrates, significantly reduces IBS symptoms and improves quality of life (QoL). Objectives: To evaluate the short- and long-term effects of LFD on improving symptom severity and the quality of life of IBS patients attending the family medicine outpatient clinic, and to assess LFD acceptability and adherence of IBS patients. Methods: Randomized control trial conducted on (123 patients) with IBS attending outpatient clinic of family medicine at Tenth of Ramadan University Hospital from 1st of June 2024 to the end of June 2025. An intervention group (No=93) received patient-centered education about LFD, and a control group (No.=90). Participants in both groups underwent an assessment of their BMI, Irritable Bowel Syndrome- Severity Scoring System (IBS-SSS), and irritable bowel syndrome-Quality of Life Measure (IBS-QOL) preintervention during the first visit and reassessed post-intervention after one, three, and six months. Additionally, Patients in the intervention group were assessed for the FODMAP Adherence Report Scale (FARS), LFD acceptability questionnaire, and Food-related QOL questionnaire at one, three-, and six-month post-intervention phases.

Conditions

Irritable Bowel Disease

Keywords

IBS, low FODMAP diet, QOL

Outcome Measures

Primary Outcomes (2)

• Irritable Bowel Syndrome-Quality of Life Measure (IBS-QOL)

  The IBS-QOL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. It consists of 34 items, each with a five-point response scale ( preintervention, postintervention at 1st, 3rd and 6th month)

  6 months

• IBS severity symptoms score (IBS-SSS)

  The IBS-SSS is a 5-question assessment to appraise the severity, frequency of abdominal pain, intensity of abdominal distention, frustration with bowel habits, and intrusion in quality of life 10 days ago ( preintervention and postintervention at 1st month, 3rd month, 6th month

  6 months

Secondary Outcomes (1)

• Body Mass Index

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

follow low fermentable- oligo-Di- monosaccharides and polyols(FODMPD) diet as intervention program

Dietary Supplement: Low Fermentable, Oligo-, Di-, Monosaccharides and Polyols (FODMAP) Diet

Control group

NO INTERVENTION

control group were patients with irritable bowel syndrome don't follow any intervention program

Interventions

Low Fermentable, Oligo-, Di-, Monosaccharides and Polyols (FODMAP) Diet DIETARY_SUPPLEMENT

The intervention group was subjected to the intervention (health education about LED) . It was conducted through patient-centered educational sessions and follow-up visits in the form of a personal interview and one to one discussion. Participants' phone number was taken for follow-up. Every 2 weeks, the patients were contacted by telephone to resolve any problems related to dietary management. The educational booklet was handled to the patient, it contained all details about how to apply the low FODMAP diet. The message delivered contained information about: Definition of IBS, diagnosis of IBS, red flags of IBS, management of IBS and role and component of low FODMAP diet in IBS. The control group received the educational booklet at the end of the study for ethical purposes.Patients in the intervention group only were asked to fill out the 3 questionnaires related to food acceptability and adherence: FODMAP Adherence Report Scale (FARS), LFD acceptability questionnaire and Food

Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• newly diagnosed with IBS based on Rome IV criteria and subtypes of IBS included constipation-predominant, diarrhea predominant, mixed, and unspecified,
• aged 18 to 60 years old of both genders,
• after taking their consent to participate

You may not qualify if:

• Patients who previously diagnosed with GI comorbidities (such as inflammatory bowel disease, celiac disease, lactose malabsorption, significant diverticular disease, or a history of bowel resection)
• Clinically significant systemic disease
• pregnant or lactating
• drug abuse
• serious psychiatric diseases
• eating disorders
• Presence of blood or pus in stool analysis
• Individuals with IBS-alarming symptoms as (did not have a normal colonoscopy)

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University outpatients clinics

Zagazig, Egypt, 44519, Egypt

Location

Related Publications (1)

• Abdallah, A. M., & Sharafeddin, M. A. Subjective sleep quality among patients with irritable bowel syndrome attending an outpatient clinic in Zagazig University Hospital. Egypt. J. Community Med.2021, 39(1), 23-31. https://doi.org/10. 21608/ ejcm.2021.144069. Nanayakkara, W. S., Skidmore, P. M., O'Brien, L., Wilkinson, T. J., and Gearry, R. B. Efficacy of the low FODMAP diet for treating irritable bowel syndrome: the evidence to date. Clinical and Experimental Gastroenterology.2016. 9, 131. Ng, Q. X., Yaow, C. Y. L., Moo, J. R., Koo, S. W. K., Loo, E. X. L., et al. A systematic review of the association between environmental risk factors and the development of irritable bowel syndrome. J. Gastroenterol. Hepatol.2024. https://doi.org/10. 1111/ jgh.16587. Barbara, G., Cremon, C., Bellini, M., Corsetti, M., Di Nardo, G., et al. Italian guidelines for the management of irritable bowel syndrome: Joint consensus from the Italian societies of gastroenterology and endoscopy (SIGE), neurogastroenterology and motility (SINGEM), hospital gastroenterologists and endoscopists (AIGO), digestive endoscopy (SIED), general medicine (SIMG), gastroenterology, hepatology and pediatric nutrition (SIGENP), and pediatrics (SIP). Dig. Liver Dis.2023, 55, 187-207. https://doi.org/10.1016/j.dld.2022.10.013. Lusetti, F., Schiepatti, A., Scalvini, D., Maimaris, S., & Biagi, F. Efficacy of a Low-FODMAP Diet for Coeliac Patients with Persistent IBS-like Symptoms despite a Gluten-Free Diet: A Systematic Review. Nutrients.2024. 16(7), 1094. https://doi.org/10. 3390/nu16071094. Van Lanen, A. S., de Bree, A., & Greyling, A. Efficacy of a low-FODMAP diet in adult irritable bowel syndrome: a systematic review and meta-analysis. Eur J Nutr.2021. 60, 3505-22. https://doi.org/10. 1007/s00394-020-02473-0. Bertin, L., Zanconato, M., Crepaldi, M., Marasco, G., Cremon, C., et al. The role of the FODMAP diet in IBS. Nutrients.2024. 16(3), 370. https://doi.org/10.3390/nu16030370.

  RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Ichthyosis Bullosa of Siemens

Interventions

Monosaccharides; polyol; Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugars; Carbohydrates; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hanaa A Nofal, MD

  Zagazig University Faculty of Human Medicine

  STUDY DIRECTOR

Study Design

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

Model Details: A randomized control trial open-label trial .The study included 93patients in intervention group and 90 patients in control group who newly diagnosed with IBS based on Rome IV criteria and subtypes of IBS included constipation-predominant, diarrhea predominant, mixed, and unspecified. The sample was collected by a systematic random sample technique. The sample was classified randomly according to intervention type into two groups (108 each group) by block randomization using sealed Envelope website. The participants were classified into 12 blocks (6 block in each group) each block size 18 list length with allocation ratio 1:1, Study was open-label. There was drop out in both intervention and control group, 15 patients were dropped out from intervention group and 21 from control group so the number of participants which completed the study were 93 in intervention group and 90 in control group.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 23, 2025
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)