Functional Gastrointestinal DisordersFGIDNCT02565355
Targeted Food Elimination for Treatment of Functional Gastrointestinal Diseases in Children
A study testing Dietary Exclusion and Standard Treatment in people with Functional Gastrointestinal Disorders and Functional Abdominal Pain Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders, Functional Abdominal Pain Syndrome, Abdominal Pain (AP)
- What is being tested?
- Dietary Exclusion and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
- Acquisition of informed consent
Who cannot join
- Children less than 5 years of age
- Organic cause of abdominal pain established by investigations (e.g. Crohn's disease)
- Diagnosis of failure-to-thrive or co-morbid chronic physical disease (e.g., Diabetes)
- Any medical condition that in the opinion of the investigator would be unsafe for trial participation.
- Lack of follow-up or failure to comply with study procedures.
About this study
Official title: Randomized Controlled Trial of Food Elimination Based on IgG Antibodies for Treatment of Functional Gastrointestinal Diseases (FGIDs) in Children
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.
Read the 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.
- Conditions
- Functional Gastrointestinal Disorders, Functional Abdominal Pain Syndrome, Abdominal Pain (AP)
- Being tested
- Dietary Exclusion, Standard Treatment
- Keywords
- Pediatric Gastroenterology
- Medical subject headings
- Gastrointestinal Diseases, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary ExclusionOther
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.
Standard TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification/Dietary Exclusion | Other | 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. Receives: Other: Dietary Exclusion |
| The Standard Treatment Group | Other | 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. Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Index: Child Form and Parent Proxy Form
Primary Outcome: The Abdominal Pain (AP) frequency and severity is calculated in each clinic visit using a 4 point questionnaire - the validated Abdominal Pain Index (API): Child Form and Parent Proxy form for age range 8 to 18 years. For age range 5 to 7 years, only the Abdominal Pain Index: Parent proxy form will be used. The 4 point scale measures the frequency of abdominal pain (Scores range 0-none to 5-every day and constant), duration of abdominal pain (scores range 0-no pain to 5-all day) and severity of abdominal pain (scores range from 0-no pain to 10-most pain). Improvement in AP is defined as >50% reduction in frequency and severity of AP in food elimination and standard treatment groups.
Measured: 4 week run in period to Visit 5 (Week 16)
Secondary outcomes (2)
KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents
The KINDL Questionnaire: self report and parent proxy versions will be used for different age groups. The KINDL questionnaire consists of 24 Likert-scaled items associated with six dimensions:physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school or nursery school/kindergarten). The sub-scales of these six dimensions can be combined to produce a total score.
Measured: 4 week run in period to Visit 5 (Week 16)
Patient Compliance
Compliance with dietary exclusion in dietary exclusion group at visits 3, 4 and 5. Compliance with conventional treatment in standard group at visits 3, 4 and 5. Adherence to advice and treatment will be measured by clinician impression at visits in both groups. (measured by consistency of completion of diaries and patient reporting of adherence to medical advice).
Measured: 4 week run in period to Visit 5 (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Dhandapani Ashok, MD, Principal investigator, Children's Hospital of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565355
- Sponsor's protocol ID
- 106580
- Acronym
- FGID
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16678566Miele 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.
PubMed 15231910Crandall 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.
PubMed 17204955Varni 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.
PubMed 17164617Christensen 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.
PubMed 1130815Huertas-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.
PubMed 18254014Huertas-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.
PubMed 24532249American 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.
PubMed 15741363Ong 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.
PubMed 20659225Carlson 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.
PubMed 24360501Chumpitazi 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.
PubMed 26104013Laird 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.
PubMed 25617048Erhart 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.
PubMed 19709410
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Food Elimination Based on IgG Antibodies for Treatment of Functional Gastrointestinal Diseases (FGIDs) in Children
- ClinicalTrials.gov ID
- NCT02565355
- Acronym / sponsor ID
- FGID / 106580
- Conditions
- Functional Gastrointestinal Disorders, Functional Abdominal Pain Syndrome, Abdominal Pain (AP)
- Keywords
- Pediatric Gastroenterology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification/Dietary Exclusion | Other | Other: Dietary ExclusionIn 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. |
| The Standard Treatment Group | Other | Other: Standard TreatmentThe 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
- Acquisition of informed consent
Key exclusion criteria (5 listed)
- Children less than 5 years of age
- Organic cause of abdominal pain established by investigations (e.g. Crohn's disease)
- Diagnosis of failure-to-thrive or co-morbid chronic physical disease (e.g., Diabetes)
- Any medical condition that in the opinion of the investigator would be unsafe for trial participation.
- Lack of follow-up or failure to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary ExclusionThe 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. | Other | Lifestyle Modification/Dietary Exclusion |
| Standard TreatmentThe 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. | Other | The Standard Treatment Group |
Primary outcome
Abdominal Pain Index: Child Form and Parent Proxy Form
Time frame: 4 week run in period to Visit 5 (Week 16)
Primary Outcome: The Abdominal Pain (AP) frequency and severity is calculated in each clinic visit using a 4 point questionnaire - the validated Abdominal Pain Index (API): Child Form and Parent Proxy form for age range 8 to 18 years. For age range 5 to 7 years, only the Abdominal Pain Index: Parent proxy form will be used. The 4 point scale measures the frequency of abdominal pain (Scores range 0-none to 5-every day and constant), duration of abdominal pain (scores range 0-no pain to 5-all day) and severity of abdominal pain (scores range from 0-no pain to 10-most pain). Improvement in AP is defined as >50% reduction in frequency and severity of AP in food elimination and standard treatment groups.
2 secondary outcomes
KINDL Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents
Time frame: 4 week run in period to Visit 5 (Week 16)
Patient Compliance
Time frame: 4 week run in period to Visit 5 (Week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 16678566Rasquin 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.
- Background: PubMed 15231910Miele 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.
- Background: PubMed 17204955Crandall 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.
- Background: PubMed 17164617Varni 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.
- Background: PubMed 1130815Christensen 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.
- Background: PubMed 18254014Huertas-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.
- Background: PubMed 24532249Huertas-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.
- Background: PubMed 15741363American 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.
- Background: PubMed 20659225Ong 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.
- Background: PubMed 24360501Carlson 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.
- Background: PubMed 26104013Chumpitazi 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.
- Background: PubMed 25617048Laird 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhandapani Ashok, MD principal investigator
Children's Hospital of Western Ontario
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Exclusion and Standard Treatment in people with Functional Gastrointestinal Disorders and Functional Abdominal Pain Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Pain Index: Child Form and Parent Proxy Form (time frame: 4 week run in period to Visit 5 (Week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565355, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.