MicrobiotaNCT07180186
Microbiota and Probiotic Therapy in Ulcerative Colitis Patients
An observational study of Microbiota and Probiotic Therapy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbiota, Probiotic Therapy, Ulcerative Colitis
- What is being tested?
- Mesalamine, Probiotics (Bacillus Clausii) and Mesalamine and probiotics (Bacillus Clausii)
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a prospective study that will be carried in Tanta University Hospital, Tropical Medicine and Infectious Diseases Department.
Who may be able to join
- Patients more than 18 years.
- Patients with ulcerative colitis in remission as assessed by the clinical activity index (CAI) ≤ 4, endoscopic index (EI) ≤ 4, and no signs of acute inflammation on histological examination.
Who cannot join
- Active ulcerative colitis.
- Cardiac, hepatic, or renal disease.
- Pregnancy.
- History of major colonic surgery.
- Patients with any malignancy.
- Previously taking other probiotics.
- Use of steroids within the last 4 weeks before study entry.
- Use of antibiotics within the last 2 weeks before study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Microbiota and Probiotic Therapy in Ulcerative Colitis Patients
This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.
Read the detailed description
Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).
The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.
Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).
- Conditions
- Microbiota, Probiotic Therapy, Ulcerative Colitis
- Being tested
- Mesalamine, Probiotics (Bacillus Clausii), Mesalamine and probiotics (Bacillus Clausii)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalamineDrug
Patients with ulcerative colitis in remission treated with oral mesalamine.
Probiotics (Bacillus Clausii)Drug
Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).
Mesalamine and probiotics (Bacillus Clausii)Drug
Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients with ulcerative colitis in remission treated with oral mesalamine. Receives: Drug: Mesalamine | |
| Group II | Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii). Receives: Drug: Probiotics (Bacillus Clausii) | |
| Group III | Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii). Receives: Drug: Mesalamine and probiotics (Bacillus Clausii) | |
| Group IV | Apparent healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Activity Index
The clinical activity index (CAI) is a tool that assesses disease activity in patients with ulcerative colitis. Seven clinical features are evaluated, with the total index score ranging from 0 to 25: 0 to 4 inactive (remission); 5 to 10 mild activity; 11 to 17 moderate activity; and ≥ 18 high activity.
CAI was measured at the study start and every 3 months through the follow up period (1year)
Measured: 12 months post-procedure
Secondary outcomes (2)
Body Mass Index
Body mass index (BMI) was measured at the study start and every 3 months during the study follow-up period
Measured: 12 months post-procedure
Gut Microbiota
Gut Microbiota was measured.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaimaa Fathy El desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180186
- Sponsor's protocol ID
- 35074/11/21
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microbiota and Probiotic Therapy in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT07180186
- Acronym / sponsor ID
- 35074/11/21
- Conditions
- Microbiota, Probiotic Therapy, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 18 Sep 2025 (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.
This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.
Detailed description
Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).
The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.
Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Drug: MesalaminePatients with ulcerative colitis in remission treated with oral mesalamine. |
| Group II | – | Drug: Probiotics (Bacillus Clausii)Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii). |
| Group III | – | Drug: Mesalamine and probiotics (Bacillus Clausii)Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii). |
| Group IV | – | –Apparent healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective study that will be carried in Tanta University Hospital, Tropical Medicine and Infectious Diseases Department.
Key inclusion criteria (2 listed)
- Patients more than 18 years.
- Patients with ulcerative colitis in remission as assessed by the clinical activity index (CAI) ≤ 4, endoscopic index (EI) ≤ 4, and no signs of acute inflammation on histological examination.
Key exclusion criteria (8 listed)
- Active ulcerative colitis.
- Cardiac, hepatic, or renal disease.
- Pregnancy.
- History of major colonic surgery.
- Patients with any malignancy.
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 |
|---|---|---|
| MesalaminePatients with ulcerative colitis in remission treated with oral mesalamine. | Drug | Group I |
| Probiotics (Bacillus Clausii)Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii). | Drug | Group II |
| Mesalamine and probiotics (Bacillus Clausii)Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii). | Drug | Group III |
Primary outcome
Clinical Activity Index
Time frame: 12 months post-procedure
The clinical activity index (CAI) is a tool that assesses disease activity in patients with ulcerative colitis. Seven clinical features are evaluated, with the total index score ranging from 0 to 25: 0 to 4 inactive (remission); 5 to 10 mild activity; 11 to 17 moderate activity; and ≥ 18 high activity. CAI was measured at the study start and every 3 months through the follow up period (1year)
2 secondary outcomes
Body Mass Index
Time frame: 12 months post-procedure
Gut Microbiota
Time frame: 12 months post-procedure
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 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Microbiota and Probiotic Therapy, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 8 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 Sep 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 Egypt. 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?
Clinical Activity Index (time frame: 12 months post-procedure). 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 Sep 2025.