Ulcerative Colitis Chronic MildPhase 3NCT03716388
Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC
A Phase 3 study testing Fecal Microbiota Transplantation and Mesalamine Granules in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Dayanand Medical College and Hospital at 1 site in India.
Trial summary
Ulcerative colitis is a chronic idiopathic inflammatory disease of the colon that is characterized by abdominal pain and bloody diarrhea. The pathogenesis of UC involves a complex interplay of genetic factors, immune dysregulation and environmental triggers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
- What is being tested?
- Fecal Microbiota Transplantation and Mesalamine Granules
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Phase 3
- 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
- Active UC:
- UC diagnosed based on history of chronic (>4 weeks), inflammatory (with blood and mucous) diarrhoea
- Total Mayo Score 4-10, Mayo endoscopic sub-score of >1
- Histopathology suggestive of UC
- No personal or family history of UC or any other autoimmune disease or malignancy
- Screened by stool microscopy and culture for common detectable enteric pathogens (Salmonella, Shigella, Campylobacter, Vibrio cholera, E. coli, Clostridium difficile, Giardia lamblia and Cryptosporidium) at the start of the study and every 4 weeks thereafter.
- Negative for antibodies against hepatitis A, C and E, hepatitis B surface antigen (HBsAg), syphilis and human immunodeficiency virus (HIV).
Who cannot join
- Severe UC (Total Mayo 11-12, Endoscopic Mayo Score 3)
- Uncertainty about diagnosis of UC : Infective colitis/ Indeterminate Colitis/ Crohn's Colitis
- Associated irritable bowel syndrome (IBS)
- Past history of surgery or colorectal surgery
- Exposure to antibiotics or probiotics in the last 4 weeks
- Patients with evidence of infections like C. difficile, cytomegalovirus, HIV, parasitic infections or extra-intestinal infections requiring antibiotics.
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- Significant cardiopulmonary co-morbidities (high risk for repeated colonoscopy)
- Pregnancy
- Refusal to consent for repeated colonoscopies.
- Donor
- Single donor (voluntary healthy individual) after informed consent
- High-risk sexual behaviors
- Communicable illnesses
- Antibiotic treatment within the past 3 months
- Intrinsic gastrointestinal illnesses such as irritable bowel syndrome, inflammatory bowel disease, gastrointestinal malignancies or major gastrointestinal surgical procedures
- Ongoing immune-modulator therapy for any concurrent illness
- Chronic pain syndromes
- Neurologic/neurodevelopmental disorders
- Metabolic syndrome
- Obesity (BMI >30 kg/m2)
- Malignant illnesses
- Donor's diet will be monitored with a diet diary.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Ajit Sood, DM
About this study
Official title: Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study
Ulcerative colitis is a chronic idiopathic inflammatory disease of the colon that is characterized by abdominal pain and bloody diarrhea. The pathogenesis of UC involves a complex interplay of genetic factors, immune dysregulation and environmental triggers. Conventional therapies for UC (including 5-aminosalicylates, corticosteroids, azathioprine or 6-mercaptopurine and biologics) focus on altering the immune response by suppression of immune cells. However, the primary pathogenic mechanism underlying UC maybe gut microbiota dysbiosis and a dysfunctional intestinal barrier resulting in an aberrant host immune response. Several studies have shown reduced microbial diversity in UC patients with under representation of anti-inflammatory phyla (Bacteroides and Firmicutes), and a relative increase of pro-inflammatory phyla (Proteobacteria and Actinobacteria). Motivated by this, therapies targeting intestinal dysbiosis (prebiotics, probiotics, synbiotics and fecal microbiota transplant (FMT)) have thus been tried in patients with UC. Though several case series and subsequently four high quality randomized controlled trails have established the efficacy of FMT in induction of remission in active UC, all these studies have used it as an add-on therapy, along with the previously ongoing conventional therapies. The investigators aim to assess the safety and efficacy of FMT as the sole modality for induction of remission in patients with newly diagnosed active UC.
Read the detailed description
This will be a prospective randomised placebo-controlled trial. Newly diagnosed treatment naive patients with mild to moderately severe UC will be recruited (n=15). The patients will be randomized into 3 groups; i.e group I (n=5): FMT with placebo, group II (n=5): FMT with mesalamine, group III (n=5): Placebo infusion with mesalamine. The patients will undergo colonoscopic administration of fecal slurry (groups I and II) or placebo (group III) at weeks 0,2,6,10 and 14. Mesalamine will be administered in a dose of 4g/day. In case of clinical worsening during the study, a short course of steroids will be added. The primary end point will be clinical remission (Mayo score ≤2, all subscores ≤ 1) at week 14. Secondary end points will be achievement of endoscopic remission (endoscopic Mayo score 0) and histological remission (Nancy grade 0, 1) at the end of 14 weeks.
- Being tested
- Fecal Microbiota Transplantation, Mesalamine Granules, Placebo infusion, Placebo granules
- Keywords
- Fecal Microbiota Transplantation, Ulcerative Colitis, Induction of Remission
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
Freshly passed stools (80 g) will be diluted with normal saline (200 ml) and homogenized using a blender, filtered, filled into 4 syringes (50 ml each) and used within 1 hour of preparation or 6 hours of passage of stools. Polyethylene glycol lavage will be done for bowel preparation and the slurry administered into the ileum and/or caecum by colonoscopy. Post FMT, recipients will be encouraged to retain the slurry for 4-6 hours. FMT sessions will be scheduled at weeks 0,2,6,10,14.
Mesalamine GranulesDrug
Also called Rowasa
Mesalamine granules 4 grams a day
Placebo infusionOther
Water with food grade colour to resemble fecal slurry
Placebo granulesOther
Granules resembling mesalamine granules, 4 grams a day
| Study group | Role | What they receive |
|---|---|---|
| FMT Vs Placebo | Experimental | Fecal microbiota transplantation (fresh sample, colonoscopic administration at weeks 0,2,6,10,14) plus placebo granules (4g/day) Receives: Biological: Fecal Microbiota Transplantation; Other: Placebo granules |
| FMT Vs Mesalamine | Active comparator | Fecal microbiota transplantation (fresh sample, colonoscopic administration at weeks 0,2,6,10,14) plus mesalamine granules (4g/day) Receives: Biological: Fecal Microbiota Transplantation; Drug: Mesalamine Granules |
| Placebo Infusion Vs Mesalamine | Active comparator | Placebo infusion (colonoscopic administration at weeks 0,2,6,10,14) plus mesalamine granules (4g/day) Receives: Drug: Mesalamine Granules; Other: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Mayo score ≤2, each subscore ≤1
Measured: Week 14
Secondary outcomes (3)
Clinical response
Reduction of Mayo score ≥30% and ≥3 points compared to baseline
Measured: Weeks 0,2,6,10,14
Endoscopic remission
Endoscopic Mayo subscore 0
Measured: Week 14
Histological remission
Nancy grade 0 or 1
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic MildStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dayanand Medical College and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Colitis & Crohn's Foundation (India)
- Responsible party
- Principal investigator, Ajit Sood, Dayanand Medical College and Hospital
- Investigators
- Ajit Sood, DM, Principal investigator, Professor and Head Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716388
- Sponsor's protocol ID
- 2018-362
- Status last verified
- Feb 2019
- First submitted
- 21 Oct 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study
- ClinicalTrials.gov ID
- NCT03716388
- Acronym / sponsor ID
- 2018-362
- Keywords
- Fecal Microbiota Transplantation, Ulcerative Colitis, Induction of Remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dayanand Medical College and HospitalUniversity, hospital or other
- Collaborators
- Colitis & Crohn's Foundation (India)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 23 Oct 2018 (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.
Ulcerative colitis is a chronic idiopathic inflammatory disease of the colon that is characterized by abdominal pain and bloody diarrhea. The pathogenesis of UC involves a complex interplay of genetic factors, immune dysregulation and environmental triggers. Conventional therapies for UC (including 5-aminosalicylates, corticosteroids, azathioprine or 6-mercaptopurine and biologics) focus on altering the immune response by suppression of immune cells. However, the primary pathogenic mechanism underlying UC maybe gut microbiota dysbiosis and a dysfunctional intestinal barrier resulting in an aberrant host immune response. Several studies have shown reduced microbial diversity in UC patients with under representation of anti-inflammatory phyla (Bacteroides and Firmicutes), and a relative increase of pro-inflammatory phyla (Proteobacteria and Actinobacteria). Motivated by this, therapies targeting intestinal dysbiosis (prebiotics, probiotics, synbiotics and fecal microbiota transplant (FMT)) have thus been tried in patients with UC. Though several case series and subsequently four high quality randomized controlled trails have established the efficacy of FMT in induction of remission in active UC, all these studies have used it as an add-on therapy, along with the previously ongoing conventional therapies. The investigators aim to assess the safety and efficacy of FMT as the sole modality for induction of remission in patients with newly diagnosed active UC.
Detailed description
This will be a prospective randomised placebo-controlled trial. Newly diagnosed treatment naive patients with mild to moderately severe UC will be recruited (n=15). The patients will be randomized into 3 groups; i.e group I (n=5): FMT with placebo, group II (n=5): FMT with mesalamine, group III (n=5): Placebo infusion with mesalamine. The patients will undergo colonoscopic administration of fecal slurry (groups I and II) or placebo (group III) at weeks 0,2,6,10 and 14. Mesalamine will be administered in a dose of 4g/day. In case of clinical worsening during the study, a short course of steroids will be added. The primary end point will be clinical remission (Mayo score ≤2, all subscores ≤ 1) at week 14. Secondary end points will be achievement of endoscopic remission (endoscopic Mayo score 0) and histological remission (Nancy grade 0, 1) at the end of 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMT Vs Placebo | Experimental | Biological: Fecal Microbiota Transplantation, Other: Placebo granulesFecal microbiota transplantation (fresh sample, colonoscopic administration at weeks 0,2,6,10,14) plus placebo granules (4g/day) |
| FMT Vs Mesalamine | Active comparator | Biological: Fecal Microbiota Transplantation, Drug: Mesalamine GranulesFecal microbiota transplantation (fresh sample, colonoscopic administration at weeks 0,2,6,10,14) plus mesalamine granules (4g/day) |
| Placebo Infusion Vs Mesalamine | Active comparator | Drug: Mesalamine Granules, Other: Placebo infusionPlacebo infusion (colonoscopic administration at weeks 0,2,6,10,14) plus mesalamine granules (4g/day) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Active UC:
Key exclusion criteria (22 listed)
- Severe UC (Total Mayo 11-12, Endoscopic Mayo Score 3)
- Uncertainty about diagnosis of UC : Infective colitis/ Indeterminate Colitis/ Crohn's Colitis
- Associated irritable bowel syndrome (IBS)
- Past history of surgery or colorectal surgery
- Exposure to antibiotics or probiotics in the last 4 weeks
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 |
|---|---|---|
| Fecal Microbiota TransplantationFreshly passed stools (80 g) will be diluted with normal saline (200 ml) and homogenized using a blender, filtered, filled into 4 syringes (50 ml each) and used within 1 hour of preparation or 6 hours of passage of stools. Polyethylene glycol lavage will be done for bowel preparation and the slurry administered into the ileum and/or caecum by colonoscopy. Post FMT, recipients will be encouraged to retain the slurry for 4-6 hours. FMT sessions will be scheduled at weeks 0,2,6,10,14. | Biological | FMT Vs Mesalamine, FMT Vs Placebo |
| Mesalamine GranulesAlso: RowasaMesalamine granules 4 grams a day | Drug | FMT Vs Mesalamine, Placebo Infusion Vs Mesalamine |
| Placebo infusionWater with food grade colour to resemble fecal slurry | Other | Placebo Infusion Vs Mesalamine |
| Placebo granulesGranules resembling mesalamine granules, 4 grams a day | Other | FMT Vs Placebo |
Primary outcome
Clinical remission
Time frame: Week 14
Mayo score ≤2, each subscore ≤1
3 secondary outcomes
Clinical response
Time frame: Weeks 0,2,6,10,14
Endoscopic remission
Time frame: Week 14
Histological remission
Time frame: Week 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Ajit Sood, DM principal investigator
Professor and Head Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal Microbiota Transplantation and Mesalamine Granules in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Dayanand Medical College and Hospital at 1 site in India.
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 7 inclusion and 22 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 12 Feb 2019. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ajit Sood, DM (+919779497094, ajitsood10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: Week 14). 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 12 Feb 2019.