Targeted Food Elimination for Treatment of Functional Gastrointestinal Diseases in Children
Condition: Functional Gastrointestinal Disorders; Functional Abdominal Pain Syndrome; Abdominal Pain (AP)
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
Study type: Interventional

Summary: 
      Recurrent Abdominal Pain (RAP) in children is common and causes significant functional
      impairment and poor quality of life. Lifestyle factors such as diet, anxiety, and stress are
      important triggers of abdominal pains, but there is lack of high quality research evidence on
      optimal treatment modalities in children. This study aims to evaluate the effect of food
      elimination on abdominal pain frequency and severity in a cohort of children with abdominal
      pain associated Functional Gastrointestinal Diseases (FGID). The primary outcome will be a
      comparison of abdominal pain frequency and severity between standard therapy and targeted
      food elimination, based on IgG antibody results to a multiple food antigen panel. The
      investigators anticipate that 'targeted dietary elimination' as a treatment strategy will
      resolve abdominal pain and improve quality of life in children.
    

Detailed description: 
      Randomized controlled single center trial. Setting: Outpatient pediatric gastroenterology
      (PG) clinic, Children's Hospital, London, Canada. Methodology: After a 4 week run in period,
      60 children aged 5-18 years, meeting Rome 3 inclusion criteria for abdominal pain associated
      FGID will be recruited to the trial. After informed consent, the participants will be
      randomized to either a standard treatment or lifestyle modification (dietary elimination)
      group in the ratio of 1:1. IgG testing to food antigens will be completed in both groups
      using a commercially available specific IgG ELISA-based multiple food allergen panel but will
      ONLY be disclosed for the lifestyle modification group. The patient will receive specific
      advice by a dietitian to exclude a maximum of two food items from his/her diet for 4 weeks.
      Children will be followed-up in PG clinic at 4-weekly intervals for 16 weeks. At every clinic
      visit, Diary of food intake, Abdominal Pain Index (API) and Quality of Life (QOL)
      questionnaire will be completed by both child and parent. The standard therapy group will
      receive conventional treatment for Abdominal Pain (AP) as per usual practice at the PG
      Clinic. Response is defined as more than 50% improvement in frequency and severity of
      abdominal pain. At each follow up visit, non-responders will cross over to the other arm of
      the study. At the end of the trial, non-responders in either group will continue to receive
      conventional treatment in the PG Clinic. Responders will be discharged back to their family
      physicians. Data will be analyzed using IBM SPSS Statistics, version 22.0.
    

Intervention name(s): Dietary Exclusion; Standard Treatment
Intervention type(s): Other; Other
Intervention description(s): The IgG antibody results will be disclosed ONLY to the patients in the lifestyle modification group by phone approximately one week after clinic visit.. 'Dietary Exclusion' will be advised by a dietitian. Patients are advised to eliminate a maximum of two foods as identified by high IgG antibody titres.; The standard therapy group will receive conventional treatment for Abdominal Pain as per usual practice at the Pediatric GI (PG) Clinic - counseling, reassurance, improving coping strategies and pain relievers as appropriate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Gastroenterology