AutismNCT00227487
Intestinal Inflammation and Carbohydrate Digestion in Autistic Children
A study testing Stool collection, Administration of carbohydrate solution during clinically indicated endoscopy and Questionnaires in people with Autism and Inflammation, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism. Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Autism, Inflammation
- What is being tested?
- Stool collection, Administration of carbohydrate solution during clinically indicated endoscopy and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to Dec 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 18 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 18 months to 17 years inclusive.
- Subjects referred to a Massachusetts General Hospital for Children (MGH Main Campus or satellite clinic) for pediatric care or pediatric gastroenterology care.
- Subjects with documented gastrointestinal symptoms requiring endoscopy and duodenal pinch biopsy for disaccharidase activity evaluation for the standard medical treatment of gastrointestinal symptoms (i.e. endoscopy and biopsy cannot be performed solely for research purposes).
Who cannot join
- Use of any proteolytic digestive enzyme supplements: prescription or over-the-counter (e.g., Pancrease [Creon-10], Lactase, etc.) up to 7 days prior to EGD with biopsy.
- Diagnosed bleeding disorder
- Hypoalbuminemia
- Unstable respiratory status evidenced by a diagnosed respiratory condition (such as asthma) that is not adequately controlled (e.g. evidence of repeated hospitalizations for exacerbations in asthma symptoms, etc.).
- Unstable cardiac status evidenced by a diagnosed cardiac condition.
- Nasal or menstrual bleeding. Additional blood in stool may effect calprotectin and lactoferrin concentration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders
The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism.
Read the detailed description
Gastrointestinal disorders in children with autism receive little attention. However, symptoms such as abdominal pain, diarrhea, constipation, and flatulence have been considered contributing to the behavioral problems. These symptoms are associated partially with the deficiency of enzymes digesting carbohydrates and inflammation of the gastrointestinal tract. The effect of intestinal inflammation on neurological disorders experienced by autistic children remains unclear. We will study this problem using recently developed non-invasive tests based on two proteins (calprotectin and lactoferrin) analysis in children's stool. Activity of enzymes needed for carbohydrate digestion will be tested in small samples of intestinal tissue. Intestinal permeability will be assessed by measuring urinary excretion of carbohydrate substances (lactulose and rhamnose) administered via the endoscope. This test will help to determine if intestinal inflammation contributes to a "leaky" gut syndrome. The study will provide valuable information for understanding the association between gastrointestinal disease and behavioral problems in autistic children.
- Conditions
- Autism, Inflammation
- Being tested
- Stool collection, Administration of carbohydrate solution during clinically indicated endoscopy, Questionnaires
- Keywords
- autism, intestine, disaccharidases, inflammation, permeability
- Medical subject headings
- Autistic Disorder, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionOther
Stool sample will be obtained by parent at home to prevent sample dilution during the cleanout
Administration of carbohydrate solution during clinically indicated endoscopyOther
- A carbohydrate solution (lactulose + rhamnose dissolved in tap water) will be administered during the procedure (upper endoscopy) through a catheter directly into the duodenum to allow for intestinal permeability analysis.
- Clinically indicated pinch biopsies will then be obtained.
- The endoscopy procedures will take at least 1 - 1 ½ hours.
- Children will then typically recover in the endoscopy suite for 2 - 2½ hours or less, if the child is medically cleared to leave the endoscopy suite sooner.
- Urine for intestinal permeability analysis will be collected during 5 hours after carbohydrate solution administration. If the child has not voided, an additional 60 minutes will be allowed for the child to void. If the child is not continent for urine, a bag will be applied to catch the specimen.
QuestionnairesOther
Parents/legal guardians of subjects will be asked to complete five (5) questionnaires: the Gastrointestinal Symptoms Inventory; a Developmental Screening for Autism - based on the child's age, either the Checklist for Autism in Toddlers (CHAT), Modified Checklist for Autism in Toddlers (M-CHAT), or the Social Communication Questionnaire (SCQ); the Behavior and Sensory Interest Questionnaire (BSI), the Behavior Problems Inventory (BPI), and the Aberrant Behavior Checklist (ABC). It should take parents/guardians no longer than eighty-five (85) minutes to complete all 5 surveys. Results from these questionnaires will be correlated with documented gastrointestinal and/or neurological diagnostic information from subject medical records and with research study test results.
| Study group | Role | What they receive |
|---|---|---|
| Stool collection, Carbohydrate administration, Questionnaires | Other | A stool sample will be obtained
A carbohydrate solution (lactulose plus rhamnose dissolved in tap water) will be administered during a clinically indicated endoscopic procedure.
Five questionnaires will be completed by parent/guardian Receives: Other: Stool collection; Other: Administration of carbohydrate solution during clinically indicated endoscopy; Other: Questionnaires |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionMay 2011
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks
- Responsible party
- Principal investigator, Rafail Kushak, Ph.D., Massachusetts General Hospital
- Investigators
- Harland S. Winter, MD, Study chair, Massachusets General HospitalTimothy M Buie, M.D., Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227487
- Sponsor's protocol ID
- KRPP1
- Status last verified
- Sep 2016
- First submitted
- 26 Sep 2005
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kushak RI, Buie TM, Murray KF, Newburg DS, Chen C, Nestoridi E, Winter HS. Evaluation of Intestinal Function in Children With Autism and Gastrointestinal Symptoms. J Pediatr Gastroenterol Nutr. 2016 May;62(5):687-91. doi: 10.1097/MPG.0000000000001174.
PubMed 26913756
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Intestinal Inflammation and Carbohydrate Digestion in Children With Autistic Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00227487
- Acronym / sponsor ID
- KRPP1
- Conditions
- Autism, Inflammation
- Keywords
- autism, intestine, disaccharidases, inflammation, permeability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Autism Speaks
- Study start
- Oct 2005
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Sep 2005 (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.
The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism.
Detailed description
Gastrointestinal disorders in children with autism receive little attention. However, symptoms such as abdominal pain, diarrhea, constipation, and flatulence have been considered contributing to the behavioral problems. These symptoms are associated partially with the deficiency of enzymes digesting carbohydrates and inflammation of the gastrointestinal tract. The effect of intestinal inflammation on neurological disorders experienced by autistic children remains unclear. We will study this problem using recently developed non-invasive tests based on two proteins (calprotectin and lactoferrin) analysis in children's stool. Activity of enzymes needed for carbohydrate digestion will be tested in small samples of intestinal tissue. Intestinal permeability will be assessed by measuring urinary excretion of carbohydrate substances (lactulose and rhamnose) administered via the endoscope. This test will help to determine if intestinal inflammation contributes to a "leaky" gut syndrome. The study will provide valuable information for understanding the association between gastrointestinal disease and behavioral problems in autistic children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stool collection, Carbohydrate administration, Questionnaires | Other | Other: Stool collection, Other: Administration of carbohydrate solution during clinically indicated endoscopy, Other: QuestionnairesA stool sample will be obtained A carbohydrate solution (lactulose plus rhamnose dissolved in tap water) will be administered during a clinically indicated endoscopic procedure. Five questionnaires will be completed by parent/guardian |
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 18 months to 17 years inclusive.
- Subjects referred to a Massachusetts General Hospital for Children (MGH Main Campus or satellite clinic) for pediatric care or pediatric gastroenterology care.
- Subjects with documented gastrointestinal symptoms requiring endoscopy and duodenal pinch biopsy for disaccharidase activity evaluation for the standard medical treatment of gastrointestinal symptoms (i.e. endoscopy and biopsy cannot be performed solely for research purposes).
Key exclusion criteria (6 listed)
- Use of any proteolytic digestive enzyme supplements: prescription or over-the-counter (e.g., Pancrease [Creon-10], Lactase, etc.) up to 7 days prior to EGD with biopsy.
- Diagnosed bleeding disorder
- Hypoalbuminemia
- Unstable respiratory status evidenced by a diagnosed respiratory condition (such as asthma) that is not adequately controlled (e.g. evidence of repeated hospitalizations for exacerbations in asthma symptoms, etc.).
- Unstable cardiac status evidenced by a diagnosed cardiac condition.
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 |
|---|---|---|
| Stool collectionStool sample will be obtained by parent at home to prevent sample dilution during the cleanout | Other | Stool collection, Carbohydrate administration, Questionnaires |
| Administration of carbohydrate solution during clinically indicated endoscopy* A carbohydrate solution (lactulose + rhamnose dissolved in tap water) will be administered during the procedure (upper endoscopy) through a catheter directly into the duodenum to allow for intestinal permeability analysis. * Clinically indicated pinch biopsies will then be obtained. * The endoscopy procedures will take at least 1 - 1 ½ hours. * Children will then typically recover in the endoscopy suite for 2 - 2½ hours or less, if the child is medically cleared to leave the endoscopy suite sooner. * Urine for intestinal permeability analysis will be collected during 5 hours after carbohydrate solution administration. If the child has not voided, an additional 60 minutes will be allowed for the child to void. If the child is not continent for urine, a bag will be applied to catch the specimen. | Other | Stool collection, Carbohydrate administration, Questionnaires |
| QuestionnairesParents/legal guardians of subjects will be asked to complete five (5) questionnaires: the Gastrointestinal Symptoms Inventory; a Developmental Screening for Autism - based on the child's age, either the Checklist for Autism in Toddlers (CHAT), Modified Checklist for Autism in Toddlers (M-CHAT), or the Social Communication Questionnaire (SCQ); the Behavior and Sensory Interest Questionnaire (BSI), the Behavior Problems Inventory (BPI), and the Aberrant Behavior Checklist (ABC). It should take parents/guardians no longer than eighty-five (85) minutes to complete all 5 surveys. Results from these questionnaires will be correlated with documented gastrointestinal and/or neurological diagnostic information from subject medical records and with research study test results. | Other | Stool collection, Carbohydrate administration, Questionnaires |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 26913756Kushak RI, Buie TM, Murray KF, Newburg DS, Chen C, Nestoridi E, Winter HS. Evaluation of Intestinal Function in Children With Autism and Gastrointestinal Symptoms. J Pediatr Gastroenterol Nutr. 2016 May;62(5):687-91. doi: 10.1097/MPG.0000000000001174.
- Related InfoLink provided by the sponsor.
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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.
Harland S. Winter, MD study chair
Massachusets General Hospital
Timothy M Buie, M.D. study director
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool collection, Administration of carbohydrate solution during clinically indicated endoscopy and Questionnaires in people with Autism and Inflammation, run by Massachusetts General Hospital at 2 sites in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227487, which also lists 1 linked publication.
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 30 Sep 2016.