Low-FODMAP Diet for FAPD in Children.
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|ClinicalTrials.gov Identifier: NCT04528914|
Recruitment Status : Unknown
Verified August 2020 by Medical University of Warsaw.
Recruitment status was: Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Functional Abdominal Pain Disorder||Other: Low-FODMAP diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|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.|
|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|
Experimental: Low-FODMAP diet
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.
- 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).
- 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].
- Change in abdominal pain frequency [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
- 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.
- 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.
- 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).
- Change in percentage of school attendance associated with IBS symptoms [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
- Change in percentage of parents' work absenteeism associated with IBS symptoms in child [ Time Frame: At week 1, 2, 3 and 4 from baseline. ]
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||8 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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,
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528914
|Contact: Agata Stróżyk, MSc||22 317 95 39 ext +firstname.lastname@example.org|
|Contact: Andrea Horvath, MD, PhD||22 317 95 39 ext +email@example.com|
|Department of Paediatrics, The Medical University of Warsaw|
|Contact: Andrea Horvath, MD, PhD 22 317 95 39 ext +48|
|Responsible Party:||Medical University of Warsaw|
|Other Study ID Numbers:||
|First Posted:||August 27, 2020 Key Record Dates|
|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.|
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|
functional abdominal pain disorders
irritable bowel syndrome
Signs and Symptoms, Digestive