Restricted FODMAPs diet
BehavioralRestricted fermentable substrate diet
NCT Number: NCT01018498
Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel syndrome in adults and children. Recently, a diet that lowers intake of a combination of foods has been found to be effective in adults with IBS identified with fructose malabsorption.
The purpose of this study is to determine whether a restricted fermentable substrate diet is effective in the treatment of irritable bowel syndrome in children.
Looking for future studies?
Notify Me7 year–17 year
All sexes
Interventional
Not applicable
Children's Nutrition Research Center, Houston, Texas, United States
Up to 19% of school-aged children have recurrent abdominal pain (RAP), accounting for 5% of all pediatric office visits and increased morbidity. The majority of children with RAP have irritable bowel syndrome (IBS) with up to 60% these children going on to develop IBS as adults. IBS accounts for up to 8 billion dollars a year of healthcare costs in adults within the United States. Successful interventions that ameliorate symptoms in childhood IBS may have an impact into adulthood, however current clinical interventions are often ineffective.
As in adults, the etiology of childhood IBS is multi-factorial, with food intolerance and increased gastrointestinal inflammation being potential factors. Another factor, that of malabsorption of fermentable substrates (e.g., fructose), has frequently been postulated as a form of food intolerance that exacerbates IBS symptoms in adults and children. Studies suggest up to 61% of children with RAP have fructose malabsorption. The interactions between factors such as increased gastrointestinal inflammation and malabsorption of fermentable substrates and they relate to an individual patient is currently unknown.
Recently, a diet that lowers intake of a combination of foods has been found to be effective in adults with IBS identified with fructose malabsorption. This diet has not been used in children with IBS nor has its mechanism(s) of efficacy been explored. This pilot project focuses on using a restricted fermentable substrate diet as a treatment in children with IBS, while evaluating decreased bacterial fermentation gas production and decreased gastrointestinal inflammation as mechanisms of its effect.
Using a prospective, open label design in children meeting Rome III childhood IBS criteria, our Specific Aims are to: 1) Characterize the effectiveness of a restricted FODMAPs diet in improving symptoms (number of abdominal pain episodes; primary endpoint); 2) To determine the mechanisms by which a restricted FODMAPs diet may work. We Hypothesize that: 1) A restricted FODMAPs diet will improve abdominal pain symptoms associated with childhood IBS and identified fructose malabsorption; 2) A restricted FODMAPs diet will improve symptoms in part by decreasing bacterial fermentation gas production amongst other potential mechanisms.
The results of this proposal may, if applied on a larger scale, aid a large number of children with IBS and potentially provide insight into the mechanism(s) behind successful dietary interventions for childhood IBS.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Restricted fermentable substrate diet
Time frame: Prior to and after 1 week of treatment
Time frame: Prior to and after 1 week of treatment
Time frame: Prior to and after 1 week of treatment
Time frame: Prior to and after 1 week of treatment
Time frame: Prior to and after 1 week of treatment
Baylor College of Medicine
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06687720
Colonic Diseases, Colonic Diseases, Functional
Ahmedabad, Gujarat, India
View Trial DetailsNCT07722572
Anxiety Disorders, Colonic Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT02136745
Colonic Diseases, Colonic Diseases, Functional
Boston, Massachusetts, United States
View Trial DetailsNCT06268717
Abdominal Pain, Alpha-Gal Syndrome
Chapel Hill, North Carolina, United States
View Trial Details