Irritable Bowel SyndromeNCT04572932
Probiotics and Irritable Bowel Syndrome
A study testing lactobacillus delbruekii in people with Irritable Bowel Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair hospital outpatient clinic, Cairo, Egypt between May and December 2019. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- lactobacillus delbruekii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 29 Feb 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)].
Who cannot join
- Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding),
- Known inflammatory bowel disease or celiac disease patients,
- patients above 50 years of age
- immuno-compromised patients
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Probiotics In Patients With Irritable Bowel Syndrome
This clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair hospital outpatient clinic, Cairo, Egypt between May and December 2019. Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.
Read the detailed description
The study includes 90 patients assigned into2 equal groups the first was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily, while the second group receivedonly itopridehcl 50mg by the same dose for four weeks.All patients fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation). Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.
Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding), Known inflammatory bowel disease or celiac disease patients, patients above 50 years of age and immuno-compromised patients were excluded from the study.
The included patients aged from 18 to 50 years fulfilling Rome IV criteria for diagnosis of IBS:Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool).Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire.
All patients were subjected to initial evaluation byfull history taking, questionnaires for (IBS diagnostic questionnaire, IBS-SSSand QOL -IBS survey), clinical examination, investigations (including CBC, ESR, CRP, random sugar, HbA1c, thyroid profile and stool analysis) and radiological assessment bypelvi-abdominal ultrasound to exclude any organic cause..Group one(45 patients) was prescribed probiotic (lactobacillus delbruekii and l. fermentum) 10billion colony forming units and itopride 50mg three times daily for four weeks while group two was prescribed only itopride 50mg three times daily for four weeks.Then reassessment of the questionnaires was done after 4 weeks of treatment for comparison
- Conditions
- Irritable Bowel Syndrome
- Being tested
- lactobacillus delbruekii
- Keywords
- intestinal microbiota,, probiotics,, quality of life,
- 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.
lactobacillus delbruekiiDrug
Also called and lactobacillus fermentum), and itopride hcl
Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl
| Study group | Role | What they receive |
|---|---|---|
| group 1:Probiotic arm | Active comparator | first group was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily for 4 weeks Receives: Drug: lactobacillus delbruekii |
| Group 2:Placcebo arm | Active comparator | the second group received only itopridehcl 50mg by the same dose for four weeks. Receives: Drug: lactobacillus delbruekii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IBS Symptoms
via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 May 2019
- Primary completion31 Dec 2019
- Study completion29 Feb 2020
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.
- More trials run by Ain Shams UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572932
- Sponsor's protocol ID
- Irritable Bowel Syndrome
- Status last verified
- Sep 2020
- First submitted
- 27 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To publish the results of this research . further studies on larger number of patients and for longer durtion as future plan
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Probiotics In Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04572932
- Acronym / sponsor ID
- Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Keywords
- intestinal microbiota,, probiotics,, quality of life,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 1 Oct 2020 (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 clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair hospital outpatient clinic, Cairo, Egypt between May and December 2019. Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.
Detailed description
The study includes 90 patients assigned into2 equal groups the first was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily, while the second group receivedonly itopridehcl 50mg by the same dose for four weeks.All patients fulfill ROME IV criteria and the IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation). Data of the patient, with suspected IBS during the study period, were reviewed and the patients who fulfilled the inclusion criteria were enrolled into this study. A written consent was obtained from all included patients. The patients who agreed to participate were then randomly assigned into two equal groups and were followed up after 4 weeks from the first visit.
Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding), Known inflammatory bowel disease or celiac disease patients, patients above 50 years of age and immuno-compromised patients were excluded from the study.
The included patients aged from 18 to 50 years fulfilling Rome IV criteria for diagnosis of IBS:Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool).Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire.
All patients were subjected to initial evaluation byfull history taking, questionnaires for (IBS diagnostic questionnaire, IBS-SSSand QOL -IBS survey), clinical examination, investigations (including CBC, ESR, CRP, random sugar, HbA1c, thyroid profile and stool analysis) and radiological assessment bypelvi-abdominal ultrasound to exclude any organic cause..Group one(45 patients) was prescribed probiotic (lactobacillus delbruekii and l. fermentum) 10billion colony forming units and itopride 50mg three times daily for four weeks while group two was prescribed only itopride 50mg three times daily for four weeks.Then reassessment of the questionnaires was done after 4 weeks of treatment for comparison
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1:Probiotic arm | Active comparator | Drug: lactobacillus delbruekiifirst group was prescribed probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and itopride hcl 50mg three times daily for 4 weeks |
| Group 2:Placcebo arm | Active comparator | Drug: lactobacillus delbruekiithe second group received only itopridehcl 50mg by the same dose for four weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-Patients should fulfill Rome Foundation IBS-Diagnostic Questionnaire i.e [Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months) associated with two or more of the following: (Related to defecation, Associated with a change in frequency of stool, Associated with a change in form of stool)].
Key exclusion criteria (5 listed)
- Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or rectal bleeding),
- Known inflammatory bowel disease or celiac disease patients,
- patients above 50 years of age
- immuno-compromised patients
- Refusal to participate in the study
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 |
|---|---|---|
| lactobacillus delbruekiiAlso: and lactobacillus fermentum), and itopride hclComarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl | Drug | Group 2:Placcebo arm, group 1:Probiotic arm |
Primary outcome
Change of IBS Symptoms
Time frame: 4 weeks
via Irritable bowel syndrom severity scale (IBS-SSS Arabic version)
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 5 Oct 2020.
- Individual participant dataSharing planned: Undecided. To publish the results of this research . further studies on larger number of patients and for longer durtion as future plan
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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?
A study testing lactobacillus delbruekii in people with Irritable Bowel Syndrome, run by Ain Shams 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 1 inclusion and 5 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 5 Oct 2020. 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?
Change of IBS Symptoms (time frame: 4 weeks). 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 5 Oct 2020.