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Targeted Food Elimination for Treatment of Functional Gastrointestinal Diseases in Children

NCT ID: NCT02565355

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Functional Gastrointestinal Disorders Functional Abdominal Pain Syndrome Abdominal Pain (AP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle Modification/Dietary Exclusion

In the lifestyle modification group, where specific IgG antibodies to foods are identified, the intervention is appropriate dietary elimination. The IgG antibody results will be disclosed and specific dietary elimination advice will be provided by an experienced dietician; provide diet alternatives to prevent nutritional deficiencies and improve adherence to diet. To improve compliance, a maximum of 2 high IgG positive foods will be eliminated at any one time in each 4 week period. Children will be followed-up in PG clinic at 4-weekly intervals for 16 weeks. Response is defined as more than 50% improvement in frequency and severity of abdominal pain. They will be assessed at visits 2, 3, 4 and 5 for follow-up, and non-responders, will cross over to the other arm of the study.

Group Type OTHER

Dietary Exclusion

Intervention Type OTHER

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 Treatment Group

The standard therapy group will not receive results of IgG antibody testing. The patients will receive conventional treatment for Abdominal Pain as per usual practice at the Pediatric GI (PG) Clinic - counseling, reassurance, improving coping strategies and pain relief as appropriate. Children will be followed-up in PG clinic at 4-weekly intervals for 16 weeks. Response is defined as more than 50% improvement in frequency and severity of abdominal pain. They will be assessed at visits 2, 3, 4 and 5 for follow-up, and non-responders, will cross over to the other arm of the study.

Group Type OTHER

Standard Treatment

Intervention Type OTHER

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.

Interventions

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Dietary Exclusion

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.

Intervention Type OTHER

Standard Treatment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Children 5-18 years of age with a diagnosis of Abdominal Pain-related FGIDs (Functional Abdominal Pain , FAP syndrome, Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine) as defined by the Rome 3 criteria.
2. Acquisition of informed consent

Exclusion Criteria

1. Children less than 5 years of age
2. Organic cause of abdominal pain established by investigations (e.g. Crohn's disease)
3. Diagnosis of failure-to-thrive or co-morbid chronic physical disease (e.g., Diabetes)
4. Any medical condition that in the opinion of the investigator would be unsafe for trial participation.
5. Lack of follow-up or failure to comply with study procedures.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dhandapani Ashok, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Western Ontario

References

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Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.

Reference Type BACKGROUND
PMID: 16678566 (View on PubMed)

Miele E, Simeone D, Marino A, Greco L, Auricchio R, Novek SJ, Staiano A. Functional gastrointestinal disorders in children: an Italian prospective survey. Pediatrics. 2004 Jul;114(1):73-8. doi: 10.1542/peds.114.1.73.

Reference Type BACKGROUND
PMID: 15231910 (View on PubMed)

Crandall WV, Halterman TE, Mackner LM. Anxiety and pain symptoms in children with inflammatory bowel disease and functional gastrointestinal disorders undergoing colonoscopy. J Pediatr Gastroenterol Nutr. 2007 Jan;44(1):63-7. doi: 10.1097/01.mpg.0000239733.79487.1e.

Reference Type BACKGROUND
PMID: 17204955 (View on PubMed)

Varni JW, Lane MM, Burwinkle TM, Fontaine EN, Youssef NN, Schwimmer JB, Pardee PE, Pohl JF, Easley DJ. Health-related quality of life in pediatric patients with irritable bowel syndrome: a comparative analysis. J Dev Behav Pediatr. 2006 Dec;27(6):451-8. doi: 10.1097/00004703-200612000-00001.

Reference Type BACKGROUND
PMID: 17164617 (View on PubMed)

Christensen MF, Mortensen O. Long-term prognosis in children with recurrent abdominal pain. Arch Dis Child. 1975 Feb;50(2):110-4. doi: 10.1136/adc.50.2.110.

Reference Type BACKGROUND
PMID: 1130815 (View on PubMed)

Huertas-Ceballos A, Logan S, Bennett C, Macarthur C. Dietary interventions for recurrent abdominal pain (RAP) and irritable bowel syndrome (IBS) in childhood. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD003019. doi: 10.1002/14651858.CD003019.pub2.

Reference Type BACKGROUND
PMID: 18254014 (View on PubMed)

Huertas-Ceballos AA, Logan S, Bennett C, Macarthur C, Martin AE. WITHDRAWN: Pharmacological interventions for recurrent abdominal pain (RAP) and irritable bowel syndrome (IBS) in childhood. Cochrane Database Syst Rev. 2014 Feb 17;2014(2):CD003017. doi: 10.1002/14651858.CD003017.pub3.

Reference Type BACKGROUND
PMID: 24532249 (View on PubMed)

American Academy of Pediatrics Subcommittee on Chronic Abdominal Pain; North American Society for Pediatric Gastroenterology Hepatology, and Nutrition. Chronic abdominal pain in children. Pediatrics. 2005 Mar;115(3):e370-81. doi: 10.1542/peds.2004-2523.

Reference Type BACKGROUND
PMID: 15741363 (View on PubMed)

Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.

Reference Type BACKGROUND
PMID: 20659225 (View on PubMed)

Carlson MJ, Moore CE, Tsai CM, Shulman RJ, Chumpitazi BP. Child and parent perceived food-induced gastrointestinal symptoms and quality of life in children with functional gastrointestinal disorders. J Acad Nutr Diet. 2014 Mar;114(3):403-413. doi: 10.1016/j.jand.2013.10.013. Epub 2013 Dec 19.

Reference Type BACKGROUND
PMID: 24360501 (View on PubMed)

Chumpitazi BP, Cope JL, Hollister EB, Tsai CM, McMeans AR, Luna RA, Versalovic J, Shulman RJ. Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. Aliment Pharmacol Ther. 2015 Aug;42(4):418-27. doi: 10.1111/apt.13286. Epub 2015 Jun 24.

Reference Type BACKGROUND
PMID: 26104013 (View on PubMed)

Laird KT, Sherman AL, Smith CA, Walker LS. Validation of the Abdominal Pain Index using a revised scoring method. J Pediatr Psychol. 2015 Jun;40(5):517-25. doi: 10.1093/jpepsy/jsu118. Epub 2015 Jan 22.

Reference Type BACKGROUND
PMID: 25617048 (View on PubMed)

Erhart M, Ellert U, Kurth BM, Ravens-Sieberer U. Measuring adolescents' HRQoL via self reports and parent proxy reports: an evaluation of the psychometric properties of both versions of the KINDL-R instrument. Health Qual Life Outcomes. 2009 Aug 26;7:77. doi: 10.1186/1477-7525-7-77.

Reference Type BACKGROUND
PMID: 19709410 (View on PubMed)

Other Identifiers

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106580

Identifier Type: -

Identifier Source: org_study_id