Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/8/2019 |
| Start Date: | November 13, 2017 |
| End Date: | December 2020 |
| Contact: | Nynke Z Borren, MD |
| Email: | nborren@mgh.harvard.edu |
| Phone: | 617-726-1997 |
Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial
The study is proposed as a single-site randomized double-blind placebo-controlled trial
requiring 4 study visits, where two of the visits are combined with their appointment for
routine clinical care. The study population will consist of patients with quiescent CD and UC
and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis
center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified
according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible
patients will be contacted at the time of their routinely scheduled office visit and
consented for the study. Self-report and review of medical records will be used to obtain
detailed information regarding their disease on an intake questionnaire completed by a
research study coordinator.
The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic
supplement compared to placebo. We propose to examine the effect of a specific probiotic
supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue
symptoms in patients with quiescent IBD.
Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline
visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.
The first follow up visit will be at week 4 to check for adverse events on study treatment,
to check accountability of probiotics/placebo, and to complete the set of questionnaires.
Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.
At week 8, subjects will receive a phone call from a study research coordinator to check in
with probiotics/placebo intake for treatment compliance and accountability records, and to
complete the set of questionnaires ascertaining subjective symptoms.
Last study visit will be at week 12 which is often combined with a regular office
appointment. Subject will provide serum blood and stool sample, as well as complete the set
of questionnaires.
requiring 4 study visits, where two of the visits are combined with their appointment for
routine clinical care. The study population will consist of patients with quiescent CD and UC
and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis
center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified
according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible
patients will be contacted at the time of their routinely scheduled office visit and
consented for the study. Self-report and review of medical records will be used to obtain
detailed information regarding their disease on an intake questionnaire completed by a
research study coordinator.
The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic
supplement compared to placebo. We propose to examine the effect of a specific probiotic
supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue
symptoms in patients with quiescent IBD.
Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline
visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.
The first follow up visit will be at week 4 to check for adverse events on study treatment,
to check accountability of probiotics/placebo, and to complete the set of questionnaires.
Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.
At week 8, subjects will receive a phone call from a study research coordinator to check in
with probiotics/placebo intake for treatment compliance and accountability records, and to
complete the set of questionnaires ascertaining subjective symptoms.
Last study visit will be at week 12 which is often combined with a regular office
appointment. Subject will provide serum blood and stool sample, as well as complete the set
of questionnaires.
Inclusion Criteria:
- Age 18-75 years
- Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
- Quiescent disease defined as Harvey Bradshaw index < 4 at baseline (week 0) or SCCAI <
2
- Persistent ongoing fatigue symptoms
- Endoscopic or radiologic remission within 12 months of screening
- Washout of non-study probiotic supplements for at least 4 weeks prior to screening.
Exclusion Criteria:
- Patients with clinical or endoscopically active inflammatory bowel disease
- Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
- Untreated severe depression or anxiety
- Known sleep disorders without adequate treatment,
- Presence of J-pouch or a stoma
- Ongoing use of other non-study probiotics
- Women who are pregnant or lactating
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