Functional Abdominal Pain Disorder Clinical Trial
Official title:
Effect of a Low-FODMAP Diet for the Management of Functional Abdominal Pain Disorders in Children
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.
| Status | Not yet recruiting |
| Enrollment | 74 |
| Est. completion date | August 2022 |
| Est. primary completion date | August 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 18 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Department of Paediatrics, The Medical University of Warsaw | Warsaw |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Warsaw | Nutricia Foundation |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in abdominal pain intensity | 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). | At week 1, 2, 3 and 4 from baseline. | |
| Secondary | Change in stool consistency | 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]. |
At week 1, 2, 3 and 4 from baseline. | |
| Secondary | Change in abdominal pain frequency | At week 1, 2, 3 and 4 from baseline. | ||
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) total score | 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. | At week 1, 2, 3 and 4 from baseline. | |
| Secondary | Change in KIDSCREEN-10 index total score | 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. | At week 1, 2, 3 and 4 from baseline. | |
| Secondary | Change in World Health Organization Five Well-Being Index (WHO-5) total score | 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). | At week 1, 2, 3 and 4 from baseline. | |
| Secondary | Change in percentage of school attendance associated with IBS symptoms | At week 1, 2, 3 and 4 from baseline. | ||
| Secondary | Change in percentage of parents' work absenteeism associated with IBS symptoms in child | At week 1, 2, 3 and 4 from baseline. | ||
| Secondary | Change in BMI-for-age z-score | 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. | At week 2 and 4 from baseline. | |
| Secondary | Percentage of compliant participants | 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. |
0-4 weeks. | |
| Secondary | Percentage of tolerability of the low-FODMAP diet | 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. | 0-4 weeks. | |
| Secondary | Adverse events | The number of all adverse events and the number of participants reporting adverse events associated with the intervention. | 0-4 weeks. |