Irritable Bowel SyndromeNCT05461833
FMT for Post-infectious IBS
A study testing Fecal transplantation, OTILONII BROMIDUM and multi-strain probiotic in people with Irritable Bowel Syndrome, run by Bogomolets National Medical University at 2 sites in Ukraine.
Trial summary
Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fecal transplantation, OTILONII BROMIDUM and multi-strain probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUkraine
- Study dates
- 1 Sep 2020to 15 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- PI-IBS diagnosis in accordance with the Rome IV criteria
- moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
- normal appearing colon on colonoscopy with biopsy that did not reveal pathology
- signed inform consent.
Who cannot join
- systemic disease, immunodeficiency, or previous treatment with immunomodulators;
- pregnant or breastfeeding;
- previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- severe current disease (hepatic, renal, respiratory, or cardiovascular);
- probiotic or antibiotic use within 8 weeks prior to study initiation;
- any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Bogomolets National Medical University
Kyiv, 01601
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
Kyiv
About this study
Official title: Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial
Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fecal transplantation, OTILONII BROMIDUM, multi-strain probiotic
- Keywords
- Irritable Bowel Syndrome, fecal microbiota transplantation, postinfectious irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal transplantationBiological
Also called Fecal microbial transplantation
Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.
OTILONII BROMIDUMDrug
Also called Spasmomen®
OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment
multi-strain probioticDietary supplement
multi-strain probiotic, oral, 1 capsule BID for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Fecal transplantation group | Experimental | Fecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon. Receives: Biological: Fecal transplantation |
| Standard-care group | Active comparator | FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID) Receives: Drug: OTILONII BROMIDUM; Dietary Supplement: multi-strain probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable bowel syndrome severity scoring system (IBS-SSS)
This questionnaire contains five questions, each with a maximum score of 100 using a visual analog scale. Total scores between 75 and 175 were considered indicative of mild IBS severity, 175-300 were moderate, and >300 were severe.
Measured: at 0, 2, 4 and 12 weeks
assesment of response rate
response rate was assessed as decrease of ≥ 50 points on the IBS-SSS
Measured: at 12 weeks
Secondary outcomes (4)
Change in BS Quality of Life Scale (IBS-QoL)
This questionnaire contains 34 items concerning the physical and psychological functioning of IBS patients in 8 domains: dysphoria, activity interference, body image, health concerns, food avoidance, social reactions, sexual function and impact on relationships.
Measured: at 0, 2, 4 and 12 weeks
Change in Fatigue Assessment Scale (FAS)
The questionnaire comprises 10 questions with 5-point-scale answers varying from never to always. Five of these questions measured physical fatigue and the other five measured mental fatigue.
Measured: at 0, 2, 4 and 12 weeks
Bacteriology measured in the stool flora by specialized non-culture techniques
The percentage of patients in each group were evaluated and characterized by a decrease below the normal content of symbiotic bacteria Bifidobacterium (less than 107 CFU / g), lactobacilli (less than 107 CFU / d), E.coli with normal properties (less than 106 CFU / d) and increase in content E.coli with altered properties (more than 106 CFU / g), pathogenic enterobacteria (not normally detected) and fungi of the genus Candida (more than 104 CFU / d)
Measured: at 0 and 1 months
Microbiome profile change
Characterization of fecal microbiome by metagenomic analysis before and after intervention Characterization of fecal microbiome by metagenomic analysis before and after intervention
Measured: at 0 and 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461833
- Sponsor's protocol ID
- FMT-PI-IBS
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT05461833
- Acronym / sponsor ID
- FMT-PI-IBS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, fecal microbiota transplantation, postinfectious irritable bowel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Collaborators
- Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 18 Jul 2022 (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.
Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal transplantation group | Experimental | Biological: Fecal transplantationFecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon. |
| Standard-care group | Active comparator | Drug: OTILONII BROMIDUM, Dietary Supplement: multi-strain probioticFODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-65 years
- PI-IBS diagnosis in accordance with the Rome IV criteria
- moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
- normal appearing colon on colonoscopy with biopsy that did not reveal pathology
- signed inform consent.
Key exclusion criteria (6 listed)
- systemic disease, immunodeficiency, or previous treatment with immunomodulators;
- pregnant or breastfeeding;
- previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- severe current disease (hepatic, renal, respiratory, or cardiovascular);
- probiotic or antibiotic use within 8 weeks prior to study initiation;
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 transplantationAlso: Fecal microbial transplantationPreparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation. | Biological | Fecal transplantation group |
| OTILONII BROMIDUMAlso: Spasmomen®OTILONII BROMIDUM , oral, 40 mg TID, 1 months of treatment | Drug | Standard-care group |
| multi-strain probioticmulti-strain probiotic, oral, 1 capsule BID for 1 month | Dietary supplement | Standard-care group |
Primary outcome
Change in Irritable bowel syndrome severity scoring system (IBS-SSS)
Time frame: at 0, 2, 4 and 12 weeks
This questionnaire contains five questions, each with a maximum score of 100 using a visual analog scale. Total scores between 75 and 175 were considered indicative of mild IBS severity, 175-300 were moderate, and >300 were severe.
assesment of response rate
Time frame: at 12 weeks
response rate was assessed as decrease of ≥ 50 points on the IBS-SSS
4 secondary outcomes
Change in BS Quality of Life Scale (IBS-QoL)
Time frame: at 0, 2, 4 and 12 weeks
Change in Fatigue Assessment Scale (FAS)
Time frame: at 0, 2, 4 and 12 weeks
Bacteriology measured in the stool flora by specialized non-culture techniques
Time frame: at 0 and 1 months
Microbiome profile change
Time frame: at 0 and 1 months
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 18 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal transplantation, OTILONII BROMIDUM and multi-strain probiotic in people with Irritable Bowel Syndrome, run by Bogomolets National Medical University at 2 sites in Ukraine.
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 5 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: finished, as of the sponsor's last update on 18 Jul 2022. 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 Ukraine. 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?
Change in Irritable bowel syndrome severity scoring system (IBS-SSS) (time frame: at 0, 2, 4 and 12 weeks). The study lists 2 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 18 Jul 2022.