Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children Clinical Trial
Official title:
Low FODMAP (Fermentable Oligo-,di-,Mono-saccharides and Polyols) Versus Gluten-free Diet in Pediatric IBS Patients; a Cross-over Randomized Trial.
Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be
relieved with defecation and a change in stool frequency and consistency. Its prevalence
among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is
defined as gastrointestinal symptoms which increase with eating gluten-containing foods and
improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and
polyols) are carbohydrates that are not absorbed well in the small intestines, therefore
fermented by gut microbiota, increasing osmotic load at the intestine causing fluid shift
and gas production. The patient suffers bloating, abdominal pain, flatulence and change of
stool consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes,
artificial sweeteners and soft drinks.
Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on
gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on
research in adults.
Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric
gastroenterology team at Hadassah. All children will record one week of baseline diet and
symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week,
together with a washout period of one week between the diets. During the two weeks of
intervention diets, the children aided by their parents will document and score symptoms
(bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure
the anticipated influence of each diet against baseline diet and symptoms.
Expected results: In previous studies, a change in symptoms was viewed within a few days. We
expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.
Outline of Study Design, including Plan of the Study and Methods:
Aims: comparing the effects of low FODMAP diet versus gluten-free diet on IBS symptoms in
children.
Study design: prospective randomized, crossover trial. Study Population: we are aiming to
recruit 40 children aged 6-18 years who answer the pediatric ROME III criteria for IBS.
Children will be recruited to the study by physicians at pediatric gastroenterology clinics.
Exclusion criteria:
1. Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
2. Patient receiving chronic medical therapy.
3. Patient already on a restrictive diet (e.g. gluten-free, lactose-free) All patients
will document baseline diet - a diary of 7 days by parents/patient specifying exact
contents of meals. They will document and score baseline symptoms including stool
consistency and frequency, abdominal pain, bloating and flatulence. The baseline
documentation will be performed by the child, or by his parents, according to the
patient's age and ability.
The patients will be randomly selected to one of the intervention groups. A clinical
dietitian has created interventional diets. Half of the patients will start with the low
FODMAP diet and half will start with Gluten free. After 7 days, the participants will return
to a 7 days washout period of their regular diet. After this period, the groups will switch
between the intervention diets, for additional 7 days. During the two weeks of intervention
diets, the patients will document and score symptoms as described for the baseline
documentation.
-There will be special consideration to several dietary elements in the baseline diet, e.g.
patients who may regularly consume high lactose, gluten or FODMAP in their daily diet.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Primary Purpose: Treatment