Inflammatory Bowel DiseasesNCT02521064
Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
Children with Crohn's disease can be effectively treated by remaining on a single-formula diet for 8 continuous weeks. This dietary therapy is known as "exclusive enteral nutrition" (EEN). It is just as effective as steroid treatment, which is what's traditionally used for the initial treatment of Crohn's disease. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Exclusive Enteral Nutrition (EEN) and Prednisone
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Aug 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (<18yo) being followed and managed through the McMaster Children's Hospital's Division of Pediatric Gastroenterology. Patients are diagnosed with Crohn's Disease, Ulcerative Colitis, or Inflammatory Bowel Disease-Unclassified.
Who may be able to join
- Children 5-18 years old who have been diagnosed with IBD (confirmed by endoscopy, histology and radiography), and are followed by McMaster Children's Hospital's Division of Pediatric Gastroenterology and Nutrition.
- Patients requiring induction therapy
- Patients already taking 5-aminosalicylic acid (5-ASA) azathioprine, 6-mercaptopurine or anti-TNF (tissue necrosis factor) therapy (e.g. infliximab)
Who cannot join
- Patients who are in remission (on maintenance therapy).
- Patients who receive new medical therapies (e.g. antibiotics, probiotics) during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Exclusive Enteral Nutrition in the Pediatric Inflammatory Bowel Disease Microbiome: a Pilot Study
Children with Crohn's disease can be effectively treated by remaining on a single-formula diet for 8 continuous weeks. This dietary therapy is known as "exclusive enteral nutrition" (EEN). It is just as effective as steroid treatment, which is what's traditionally used for the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated. One possibility is that it changes the bacteria in our intestines, which allows the intestine to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a disease that is very similar to Crohn's disease. The purpose of our research project is to determine whether EEN can be used to treat ulcerative colitis, and understand how the intestinal bacteria changes while on EEN. Investigators will compare the results to patients who have either Crohn's disease or ulcerative colitis, and are receiving standard treatment for their disease (steroids). This is a pilot study, meaning that the goal of this study is to determine whether a larger study is feasible. Investigators will measure patient recruitment rates, whether patients are able to perform the treatment as requested, whether there are any safety concerns, and whether investigators are able to collect the bloodwork and stool samples without difficulty.
Read the detailed description
Exclusive enteral nutrition (EEN) is an effective induction therapy in pediatric Crohn's disease (CD). Compared to corticosteroids, EEN has equivalent rates of clinical remission and significantly higher rates of mucosal healing and weight gain. There is a paucity of literature on the role of EEN in ulcerative colitis (UC). Some have postulated that colonic disease will not respond to EEN, yet two series found no difference in rates of clinical remission between small intestinal and colonic CD. The mechanisms underlying the effectiveness of enteral nutrition in colitis remain unclear. A microbiome-mediated pathogenesis is possible. Two studies have shown how EEN produces profound changes in microbial community structure within as little as 24 hours. These changes correlated with improved disease activity scores. Active inflammatory bowel disease also carries distinct microbial signatures. Baseline differences in taxonomy between IBD phenotypes may account for differences in EEN efficacy between CD and UC.
The purpose of the pilot study is to investigate if EEN can be used for induction of remission of ulcerative colitis, and compare its usage to a) corticosteroids for UC and b) EEN or corticosteroids for Crohn's disease. The goal is to eventually characterize the clinical, biochemical and microbial changes that occur with each. However, given that EEN is a challenging commitment, as a sole source of nutrition for 8 weeks, investigators first have to evaluate feasibility in terms of participant recruitment, compliance and safety of this treatment. Both EEN and corticosteroid treatment require proper compliance to be effective, which can be a significant burden for the patient and his/her family. Investigators will therefore also determine satisfaction with the induction therapies and effect on quality of life. Further, since frequent follow up is being requested, investigators need to assess recruitment and retention rates, as well as compliance with completing bloodwork and providing stool samples. Investigators hypothesize that these induction therapies will be both feasible and safe. However, it is anticipated that, while patients will be satisfied with the treatment, it may have a significant impact on quality of life during those 8 week.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Exclusive Enteral Nutrition (EEN), Prednisone
- Keywords
- IBD, enteral nutrition, corticosteroids
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral Nutrition (EEN)Dietary supplement
Also called Peptamen 1.5
Patients will be treated with 8 weeks of Exclusive Enteral Nutrition (EEN). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.
PrednisoneDrug
Also called Corticosteroid
Patients will be treated with 8 weeks of prednisone (corticosteroid). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Enteral Nutrition (EEN) | The patient will be admitted to hospital for placement of the nasogastric tube and commencement of exclusive enteral nutrition (EEN). Nutritional feeds will consist of a semi-elemental (whey-peptide based) formula that will make up all of the patient's daily caloric needs (120% of BMR). Feeds will slowly be titrated up to full volume and strength during the hospital stay. The patient will receive instructions how to decrease the number of hours of feeds once at home. The patient will be seen in clinic at two weeks and will receive a phone call from the dietician at 4 weeks to assess progress and symptom improvement. At 8 weeks, food will start to be reintroduced slowly, as per the dietician's instructions. Receives: Dietary Supplement: Exclusive Enteral Nutrition (EEN) | |
| Prednisone | Patients who receive the prednisone intervention will follow the Division of Pediatric Gastroenterology and Nutrition protocol for corticosteroid induction therapy, with 2 weeks of high dose IV/PO prednisone (maximum 40mg/day) followed by a 6 week wean (approximately decreasing 5mg/day per week). The patient will receive a phone call from the nurse practitioner at two weeks and will be seen in clinic at 4 weeks to assess progress and symptom improvement. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Participant recruitment rate
Number of participants recruited per month
Measured: Entirety of study (1 year)
Feasibility: Participant retention rate
Number of participants enrolled who did not complete the study
Measured: Entirety of study (1 year)
Feasibility: Participant compliance with intervention: treatment (EEN or corticosteroids)
Number of participants who completed full treatment duration
Measured: Entirety of study (1 year)
Feasibility: Participant compliance with intervention: bloodwork, stool and urine sampling
Number of blood, stool and urine sample collections per participant
Measured: Entirety of study (1 year)
Feasibility: Participant compliance with weekly interviews
Number of weekly interviews completed per participant
- Interviews discussing: a) disease assessment (Pediatric Ulcerative Colitis Activity Index [PUCAI]/Pediatric Crohn's Disease Activity Index [PCDAI] scores), and b) quality of life (health-related quality of life questionnaire)
Measured: Entirety of study (1 year)
Feasibility: Rate of adverse events in patients with ulcerative colitis receiving EEN
Record of all adverse events
Measured: Entirety of study (1 year)
Secondary outcomes (4)
Changes in microbiome (composite measure)
Changes in microbial community structure in patients receiving EEN versus corticosteroid induction therapy. Multiple indices of alpha and beta diversity will comprise composite assessment of microbiome change.
Measured: Entirety of study (1 year)
Clinical remission (composite measure)
Effects of EEN therapy on induction of clinical remission in pediatric UC versus CD. Composite assessment consisting of:
- 8 weeks: PUCAI Δ ≥20; PCDAI Δ ≥15, decrease in serum ESR, CRP, and fecal calprotectin
- 12 weeks: PUCAI <10; PCDAI <15, Normalization of serum ESR, CRP and fecal calprotectin)
Measured: Entirety of study (1 year)
Patient satisfaction and quality of life
Patient satisfaction with the treatment (satisfaction validated questionnaire)
Measured: Entirety of study (1 year)
Patient quality of life
Quality of life during induction therapy (quality of life validated questionnaire)
Measured: Entirety of study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Gastroenterology
- Responsible party
- Principal investigator, Lara Hart, McMaster Children's Hospital
- Investigators
- Nikhil Pai, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521064
- Sponsor's protocol ID
- McmasterCH - 15-365
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exclusive Enteral Nutrition in the Pediatric Inflammatory Bowel Disease Microbiome: a Pilot Study
- ClinicalTrials.gov ID
- NCT02521064
- Acronym / sponsor ID
- McmasterCH - 15-365
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, enteral nutrition, corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Collaborators
- Canadian Association of Gastroenterology
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Aug 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.
Children with Crohn's disease can be effectively treated by remaining on a single-formula diet for 8 continuous weeks. This dietary therapy is known as "exclusive enteral nutrition" (EEN). It is just as effective as steroid treatment, which is what's traditionally used for the initial treatment of Crohn's disease. It is not clear why EEN is an effective treated. One possibility is that it changes the bacteria in our intestines, which allows the intestine to heal. It is also unclear whether EEN can be used to treat ulcerative colitis, a disease that is very similar to Crohn's disease. The purpose of our research project is to determine whether EEN can be used to treat ulcerative colitis, and understand how the intestinal bacteria changes while on EEN. Investigators will compare the results to patients who have either Crohn's disease or ulcerative colitis, and are receiving standard treatment for their disease (steroids). This is a pilot study, meaning that the goal of this study is to determine whether a larger study is feasible. Investigators will measure patient recruitment rates, whether patients are able to perform the treatment as requested, whether there are any safety concerns, and whether investigators are able to collect the bloodwork and stool samples without difficulty.
Detailed description
Exclusive enteral nutrition (EEN) is an effective induction therapy in pediatric Crohn's disease (CD). Compared to corticosteroids, EEN has equivalent rates of clinical remission and significantly higher rates of mucosal healing and weight gain. There is a paucity of literature on the role of EEN in ulcerative colitis (UC). Some have postulated that colonic disease will not respond to EEN, yet two series found no difference in rates of clinical remission between small intestinal and colonic CD. The mechanisms underlying the effectiveness of enteral nutrition in colitis remain unclear. A microbiome-mediated pathogenesis is possible. Two studies have shown how EEN produces profound changes in microbial community structure within as little as 24 hours. These changes correlated with improved disease activity scores. Active inflammatory bowel disease also carries distinct microbial signatures. Baseline differences in taxonomy between IBD phenotypes may account for differences in EEN efficacy between CD and UC.
The purpose of the pilot study is to investigate if EEN can be used for induction of remission of ulcerative colitis, and compare its usage to a) corticosteroids for UC and b) EEN or corticosteroids for Crohn's disease. The goal is to eventually characterize the clinical, biochemical and microbial changes that occur with each. However, given that EEN is a challenging commitment, as a sole source of nutrition for 8 weeks, investigators first have to evaluate feasibility in terms of participant recruitment, compliance and safety of this treatment. Both EEN and corticosteroid treatment require proper compliance to be effective, which can be a significant burden for the patient and his/her family. Investigators will therefore also determine satisfaction with the induction therapies and effect on quality of life. Further, since frequent follow up is being requested, investigators need to assess recruitment and retention rates, as well as compliance with completing bloodwork and providing stool samples. Investigators hypothesize that these induction therapies will be both feasible and safe. However, it is anticipated that, while patients will be satisfied with the treatment, it may have a significant impact on quality of life during those 8 week.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive Enteral Nutrition (EEN) | – | Dietary Supplement: Exclusive Enteral Nutrition (EEN)The patient will be admitted to hospital for placement of the nasogastric tube and commencement of exclusive enteral nutrition (EEN). Nutritional feeds will consist of a semi-elemental (whey-peptide based) formula that will make up all of the patient's daily caloric needs (120% of BMR). Feeds will slowly be titrated up to full volume and strength during the hospital stay. The patient will receive instructions how to decrease the number of hours of feeds once at home. The patient will be seen in clinic at two weeks and will receive a phone call from the dietician at 4 weeks to assess progress and symptom improvement. At 8 weeks, food will start to be reintroduced slowly, as per the dietician's instructions. |
| Prednisone | – | Drug: PrednisonePatients who receive the prednisone intervention will follow the Division of Pediatric Gastroenterology and Nutrition protocol for corticosteroid induction therapy, with 2 weeks of high dose IV/PO prednisone (maximum 40mg/day) followed by a 6 week wean (approximately decreasing 5mg/day per week). The patient will receive a phone call from the nurse practitioner at two weeks and will be seen in clinic at 4 weeks to assess progress and symptom improvement. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (<18yo) being followed and managed through the McMaster Children's Hospital's Division of Pediatric Gastroenterology. Patients are diagnosed with Crohn's Disease, Ulcerative Colitis, or Inflammatory Bowel Disease-Unclassified.
Key inclusion criteria (3 listed)
- Children 5-18 years old who have been diagnosed with IBD (confirmed by endoscopy, histology and radiography), and are followed by McMaster Children's Hospital's Division of Pediatric Gastroenterology and Nutrition.
- Patients requiring induction therapy
- Patients already taking 5-aminosalicylic acid (5-ASA) azathioprine, 6-mercaptopurine or anti-TNF (tissue necrosis factor) therapy (e.g. infliximab)
Key exclusion criteria (2 listed)
- Patients who are in remission (on maintenance therapy).
- Patients who receive new medical therapies (e.g. antibiotics, probiotics) during the study period
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 |
|---|---|---|
| Exclusive Enteral Nutrition (EEN)Also: Peptamen 1.5Patients will be treated with 8 weeks of Exclusive Enteral Nutrition (EEN). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted. | Dietary supplement | Exclusive Enteral Nutrition (EEN) |
| PrednisoneAlso: CorticosteroidPatients will be treated with 8 weeks of prednisone (corticosteroid). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted. | Drug | Prednisone |
Primary outcome
Feasibility: Participant recruitment rate
Time frame: Entirety of study (1 year)
Number of participants recruited per month
Feasibility: Participant retention rate
Time frame: Entirety of study (1 year)
Number of participants enrolled who did not complete the study
Feasibility: Participant compliance with intervention: treatment (EEN or corticosteroids)
Time frame: Entirety of study (1 year)
Number of participants who completed full treatment duration
Feasibility: Participant compliance with intervention: bloodwork, stool and urine sampling
Time frame: Entirety of study (1 year)
Number of blood, stool and urine sample collections per participant
Feasibility: Participant compliance with weekly interviews
Time frame: Entirety of study (1 year)
Number of weekly interviews completed per participant * Interviews discussing: a) disease assessment (Pediatric Ulcerative Colitis Activity Index [PUCAI]/Pediatric Crohn's Disease Activity Index [PCDAI] scores), and b) quality of life (health-related quality of life questionnaire)
Feasibility: Rate of adverse events in patients with ulcerative colitis receiving EEN
Time frame: Entirety of study (1 year)
Record of all adverse events
4 secondary outcomes
Changes in microbiome (composite measure)
Time frame: Entirety of study (1 year)
Clinical remission (composite measure)
Time frame: Entirety of study (1 year)
Patient satisfaction and quality of life
Time frame: Entirety of study (1 year)
Patient quality of life
Time frame: Entirety of study (1 year)
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 2 May 2017.
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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.
Nikhil Pai, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by McMaster Children's Hospital at 1 site in Canada.
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 2 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
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?
Feasibility: Participant recruitment rate (time frame: Entirety of study (1 year)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2017.