Inflammatory Bowel DiseasesNCT03266484
Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease
A study testing Probiotic Mixture in people with Inflammatory Bowel Diseases and Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Probiotic Mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 1 Jul 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Crohn's and Colitis Center, MGH
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read more
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.
- Being tested
- Probiotic Mixture, Placebo
- Keywords
- Microbiome, Fatigue, Probiotics
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic MixtureDietary supplement
The probiotic supplement contains 8 different strains of bacteria and participants will be dosed in two dosages per a total of 40 billion bacteria daily.
PlaceboDietary supplement
A placebo which is identical to the probiotic mixture. Participants will be dosed in two dosages daily.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Mixture | Active comparator | Participants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo.
The probiotics sachets will be taken twice a day for 12 weeks. Receives: Dietary Supplement: Probiotic Mixture |
| Placebo | Placebo comparator | Participants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo
The identical placebo sachets will be taken twice a day for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiome
Change in fecal microbiome pattern assessed using 16sRNA sequencing.
Measured: Week 12
Change in serum inflammatory cytokines levels
Change in inflammatory cytokines will be performed using the Biosciences Cytometric Bead Array kits.
Measured: Week 12
Change in metabolomic profiles
Change in metabolic profiling will be performed on serum samples using established targeted quantitative and semi-quantitative gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) methods
Measured: Week 12
Change in fatigue symptoms
Reduction of fatigue symptoms which will be assessed using FACIT-F questionnaire. FACIT-F score of >43 at week 4 or week 12
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start13 Nov 2017
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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 Inflammatory Bowel DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Bio Industries BV
- Responsible party
- Principal investigator, Ashwin Ananthakrishnan, Massachusetts General Hospital
- Investigators
- Ashwin N Ananthakrishnan, MBBS, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266484
- Sponsor's protocol ID
- 2017P001489
- Status last verified
- May 2025
- First submitted
- 25 Aug 2017
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borren NZ, Paulides E, Klaassen MAY, Alm E, Xavier RJ, van der Woude CJ, Ananthakrishnan AN. Microbiome-Directed Therapy for Fatigue in Quiescent Inflammatory Bowel Disease: A Randomized Placebo-Controlled Trial of Multistrain Probiotic Supplementation. Am J Gastroenterol. 2026 May 19. doi: 10.14309/ajg.0000000000004056. Online ahead of print.
PubMed 42153706
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03266484
- Acronym / sponsor ID
- 2017P001489
- Keywords
- Microbiome, Fatigue, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Winclove Bio Industries BV
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 30 Aug 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Mixture | Active comparator | Dietary Supplement: Probiotic MixtureParticipants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo. The probiotics sachets will be taken twice a day for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants who are meeting the inclusion criteria will be randomized to either the probiotic mixture or an identical placebo The identical placebo sachets will be taken twice a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Probiotic MixtureThe probiotic supplement contains 8 different strains of bacteria and participants will be dosed in two dosages per a total of 40 billion bacteria daily. | Dietary supplement | Probiotic Mixture |
| PlaceboA placebo which is identical to the probiotic mixture. Participants will be dosed in two dosages daily. | Dietary supplement | Placebo |
Primary outcome
Change in gut microbiome
Time frame: Week 12
Change in fecal microbiome pattern assessed using 16sRNA sequencing.
Change in serum inflammatory cytokines levels
Time frame: Week 12
Change in inflammatory cytokines will be performed using the Biosciences Cytometric Bead Array kits.
Change in metabolomic profiles
Time frame: Week 12
Change in metabolic profiling will be performed on serum samples using established targeted quantitative and semi-quantitative gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) methods
Change in fatigue symptoms
Time frame: Week 4 and Week 12
Reduction of fatigue symptoms which will be assessed using FACIT-F questionnaire. FACIT-F score of >43 at week 4 or week 12
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 9 May 2025.
- Derived from this study: PubMed 42153706Borren NZ, Paulides E, Klaassen MAY, Alm E, Xavier RJ, van der Woude CJ, Ananthakrishnan AN. Microbiome-Directed Therapy for Fatigue in Quiescent Inflammatory Bowel Disease: A Randomized Placebo-Controlled Trial of Multistrain Probiotic Supplementation. Am J Gastroenterol. 2026 May 19. doi: 10.14309/ajg.0000000000004056. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Ashwin N Ananthakrishnan, MBBS, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Mixture in people with Inflammatory Bowel Diseases and Crohn Disease, run by Massachusetts General Hospital at 1 site 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 6 inclusion and 7 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 9 May 2025. 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 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. Some participants in this study may receive a placebo. 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?
Change in gut microbiome (time frame: Week 12). The study lists 4 primary outcomes in all. 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 NCT03266484, 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 9 May 2025.