Efficacy of a Low FODMAP Diet in IBS Children and Impact on Urinary and Faecal Metabolome

NCT06618677 | Completed

• 1 other identifier: IBS-FODMAP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation, or changes in stool frequency or stool form . The low FODMAPs diet (LFD) is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates. FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods. FODMAPs include oligosaccharides (fructans, fructo-oligosaccharides = FOS and galacto-oligosaccharides = GOS), disaccharides (lactose), monosaccharides (fructose), and polyols (sorbitol, mannitol, maltitol, xylitol, polydextrose, and isomalt). Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms, particularly bloating and abdominal pain. On the other hand, evidences in children are scarce. Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet (HFD), providing interesting hypotheses for pathophysiological mechanisms in IBS. Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS. Moreover, the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs (SFD) on the fecal and urinary metabolomic profile of pediatric IBS patients. This is a single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari. The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial. Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet.

Conditions

IBS; Functional Gastrointestinal Disorders

Keywords

FODMAPs; IBS

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale

  0-10

  from running in and during all the dietetic treatment

• Irritable bowel Syndrome-Severity score

  Is a five-item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life, scoring from 0 to 500. Cut-off of to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS

  15 days

Secondary Outcomes (1)

• Fecal and urinary Metabolome

  14 days

Study Arms (2)

LOW FODMAP-wash out- STANDARD FODMAPs

ACTIVE COMPARATOR

Arm starting with low fodmap diet

Other: LOW FODMAPs Diet

STANDARD FODMAPs-wash out-LOW FODMAP

ACTIVE COMPARATOR

Arm starting with standard fodmap diet

Other: LOW FODMAPs Diet

Interventions

LOW FODMAPs Diet OTHER

patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms started the wash-out period of two weeks and subsequently started the final 2-week period on standard or low FODMAP diet. The LFD will have a FODMAP content expressed in grams 0.15 g/kg/d FODMAPs (maximum 10 g/day) while the SFD will contain 0.7 g/kg/d FODMAPs (maximum 60 g/day).

Also known as: STANDARD FODMAPs Diet

LOW FODMAP-wash out- STANDARD FODMAPs; STANDARD FODMAPs-wash out-LOW FODMAP

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a) age between 4 and 18 years; b) diagnosis of IBS according to Rome IV criteria; c) absence of other organic diseases; d) feeding via the oral route; e) ability to read and comprehend any employed questionnaires/scales; f) signed informed consent;

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270

Bari, Ba, 70126, Italy

Location

Related Publications (4)

• Caponio GR, Celano G, Calabrese FM, Riezzo G, Orlando A, D'Attoma B, Ignazzi A, Vacca M, Porrelli A, Tutino V, De Angelis M, Giannelli G, Russo F. Evaluation of the Effects of the Tritordeum-Based Diet Compared to the Low-FODMAPs Diet on the Fecal Metabolome of IBS-D Patients: A Preliminary Investigation. Nutrients. 2022 Nov 2;14(21):4628. doi: 10.3390/nu14214628.

  PMID: 36364888 RESULT

• Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.

  PMID: 25016597 RESULT

• Staudacher HM, Lomer MCE, Farquharson FM, Louis P, Fava F, Franciosi E, Scholz M, Tuohy KM, Lindsay JO, Irving PM, Whelan K. A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. Gastroenterology. 2017 Oct;153(4):936-947. doi: 10.1053/j.gastro.2017.06.010. Epub 2017 Jun 15.

  PMID: 28625832 RESULT

• Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.

  PMID: 27144632 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ruggiero Francavilla, Prof

  Interdisciplinary department of Medicine Pediatric section. University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: single center, prospective, single blind low versus standard FODMAPs diet trial with crossover

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: October 1, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available on request
• Access Criteria: Request via email at fernandacristofori@gmail.com

Locations

IT (1)