Low-FODMAP Diet for FAPD in Children.

• ClinicalTrials.gov Identifier: NCT04528914
• Recruitment Status: Unknown
• First Posted: August 27, 2020
• Last Update Posted: August 27, 2020
• Sponsor: Medical University of Warsaw
• Collaborator: Nutricia Foundation
• Information provided by (Responsible Party): Medical University of Warsaw

Study Description

Brief Summary:

This single-center, randomized, controlled, quadruple-blinded, superiority trial is performed to test the hypothesis that children with IBS and FAP-NOS who receive a low-FODMAP diet will have a lower mean abdominal pain intensity score compared with those who receive a regular diet after 4 weeks of intervention.

Condition or disease	Intervention/treatment	Phase
Functional Abdominal Pain Disorder	Other: Low-FODMAP diet	Not Applicable

Detailed Description:

Introduction. Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders. However, in children with FAPDs, there is a need for high-quality evidence regarding the dietary management. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs.

Methods. In this trial, seventy-four children aged 8 to 18 years with a Functional Abdominal Pain Disorder (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks.A primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The research investigators, outcome assessor, and independent statistician (data analyst) will be blinded until the completion of the data analysis.The dietitian will remain unblinded. Success of blinding will be assessed after completion of the follow-up period.
• Primary Purpose: Treatment
• Official Title: Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
• Estimated Study Start Date: September 2020
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low-FODMAP diet; 37 participants.	Other: Low-FODMAP diet; The low-FODMAP diet will contain the amount of FODMAPs that will not exceed the cut-offs for each FODMAP sugar per serving of food per sitting. Diets will be individually tailored by dietitian and delivered by a catering company (five meals each day).
No Intervention: Regular diet; 37 participants. The regular diet will reflect the habitual FODMAP intake in a normal diet. Diets in both groups will be matched in terms of total energy, fat, protein, carbohydrates and dietary fiber with the usual participant's diet.

Outcome Measures

Primary Outcome Measures :

1. Change in abdominal pain intensity [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
   The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a 100-mm Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS).

Secondary Outcome Measures :

1. Change in stool consistency [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]

   Bristol Stool Scale is a seven-point scale that distinguish seven pictures of different forms of stool, ranging from the hardest (type 1) to the softest (type 7).

   At baseline, participants with IBS and a stool consistency score > 5 on the Bristol Stool Scale will be classified as having IBS with predominant diarrhea (IBS-D); if the stool consistency score is < 3, the subjects will be classified as having IBS with predominant constipation (IBS-C).

   Responders will be subjects with improvement in their average stool consistency during the last week of the trial compared with baseline [≥1 higher Bristol Stool Scale score in case of IBS with predominant constipation, or at least one lower score in case of IBS with predominant diarrhea].

2. Change in abdominal pain frequency [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
3. Change in Gastrointestinal Symptom Rating Scale (GSRS) total score [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
   The GSRS is a 15-item interview-based rating scale. Each item is assessed in a seven-point graded Likert-type scale (one means no symptoms, and seven represents very troublesome symptoms), then total score is calculated.
4. Change in KIDSCREEN-10 index total score [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
   KIDSCREEN-10 index is a 11-item instrument to assess health-related quality of life (HRQoL). Each item is assessed in a 5-point scale with higher values indicating a higher HRQoL. Total score is calculated.
5. Change in World Health Organization Five Well-Being Index (WHO-5) total score [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
   The WHO-5 consists of five statements regarding the physical well-being, assessed in a six-point scale (in which zero means at no time, and five represents all of the time). Total raw score is then calculated, ranging from 0 to 25 which is multiplied by four, therefore the final score ranges from 0 (the worst imaginable well-being) to 100 (the best imaginable well-being).
6. Change in percentage of school attendance associated with IBS symptoms [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
7. Change in percentage of parents' work absenteeism associated with IBS symptoms in child [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
8. Change in BMI-for-age z-score [ Time Frame: At week 2 and 4 from baseline. ]
   The BW (kg) and standing height (cm) will be measured following standard methods. Body Mass Index (BMI) will be calculated using the standard equation. BMI-for-age z-score will be computed using the WHO AnthroPlus software v1.0.4., then assessed and monitored over time using the WHO growth charts.
9. Percentage of compliant participants [ Time Frame: 0-4 weeks. ]

   The percentage compliance in each group will be calculated. A compliant participant is considered as one who consumes at least 80% of the provided diet.

   The percent of each meal which the subject consumed (<50%, 50-79% or 80-100%) each day will be reported by participant in a study diary (developed by research team); the additional snacks consumed also will be reported daily (characteristics and amount). Snacks and meals outside the meal plan will be assessed separately.

10. Percentage of tolerability of the low-FODMAP diet [ Time Frame: 0-4 weeks. ]
    The tolerability (acceptability) of the diet will be assessed each day using a 100-mm Visual Analogue Scale and reported in the subject diary. This outcome will be reported as a mean for each study group, and as a comparison between groups.
11. Adverse events [ Time Frame: 0-4 weeks. ]
    The number of all adverse events and the number of participants reporting adverse events associated with the intervention.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• functional abdominal pain - not otherwise specified (FAP-NOS) or irritable bowel syndrome (IBS) diagnosed according to the Rome IV Criteria,
• baseline average pain intensity at least 30 mm on a 100-mm Visual Analogue Scale,
• feeding via the oral route,
• ability to read and comprehend any employed questionnaires/scales,
• signed informed consent,
• stated availability throughout the study period.

Exclusion Criteria:

• receiving any other intervention/treatment with regard to FAP-NOS or IBS or those who received any other intervention during the last 3 months,
• an organic cause of symptoms or organic gastrointestinal disease,
• chronic illness, receiving medications which affect gastrointestinal motility,
• need for any other dietary management which could make the balancing or compliance with the diet troublesome,
• previously diagnosed carbohydrate intolerance without symptoms of FAPD after implementation of an exclusion diet,
• undernutrition (defined as World Health Organization [WHO] growth charts < -2 SD), decreased growth velocity (sharp decline in growth line), or overweight or obese (> 1 or > 2 SD on the WHO growth charts, respectively),
• unintentional weight loss greater or equal to 5% of subject' body weight within the previous 3 months,
• pregnancy,
• eating disorders,
• prior surgery of the gastrointestinal tract (within last 3 months),
• recurrent or unexplained fever,
• developmental disabilities which impair the ability of the child to understand or communicate.

Contacts and Locations

Contacts

Contact: Agata Stróżyk, MSc; 22 317 95 39 ext +48; ag.strozyk@gmail.com

Contact: Andrea Horvath, MD, PhD; 22 317 95 39 ext +48; andrea.hania@gmail.com

Locations

Poland

Department of Paediatrics, The Medical University of Warsaw

Warsaw, Poland

Contact: Andrea Horvath, MD, PhD 22 317 95 39 ext +48

Sponsors and Collaborators

Medical University of Warsaw

Nutricia Foundation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strozyk A, Horvath A, Muir J, Szajewska H. Effect of a low-FODMAP diet for the management of functional abdominal pain disorders in children: a study protocol for a randomized controlled trial. Nutr J. 2021 Jan 2;20(1):1. doi: 10.1186/s12937-020-00656-3.

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT04528914
• Other Study ID Numbers: 1W44/5FNUT13/20
• First Posted: August 27, 2020
• Last Update Posted: August 27, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Up to 3 years after completion of data analysis.
• Access Criteria: The datasets will be made available from the contact author upon reasonable request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:

functional abdominal pain disorders; irritable bowel syndrome; diet

Additional relevant MeSH terms:

Abdominal Pain; Somatoform Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Mental Disorders