Irritable Bowel SyndromeNCT05523427
Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome
A study testing Two probiotic strains (L. plantarum and L. acidophilus) in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by University of Mosul at 1 site in Iraq.
Trial summary
Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Two probiotic strains (L. plantarum and L. acidophilus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 19 Jul 2022to 6 Jan 2023
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-55
- Both genders
- Patients diagnosed clinically with IBS based on Rome's criteria
- IBS-Diarrhea only with pain \& distention
- Duration of symptoms 6 months
Who cannot join
- Age > 55
- Celiac disease
- Inflammatory bowel disease (ulcerative colitis \& Crohn's)
- Thyroid disease
- Colonic CA
- Lactose intolerance
Show all 9Show fewer
- Alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of GIT malignancy)
- Preexisting use of antibiotics in the previous 3 months.
- Preexisting systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial
Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS
Read the detailed description
Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.
- Being tested
- Two probiotic strains (L. plantarum and L. acidophilus)
- Keywords
- IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, Mucus, L. plantarum, L. acidophilus
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two probiotic strains (L. plantarum and L. acidophilus)Dietary supplement
A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment of IBS | No intervention | Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals. |
| Probiotics + Standard treatment of IBS | Experimental | A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS. Receives: Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.
The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start19 Jul 2022
- Primary completion21 Dec 2022
- Study completion6 Jan 2023
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mosul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radhwan Al-Zidan, University of Mosul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523427
- Sponsor's protocol ID
- CCMRE-phA-22-11
- Status last verified
- Jan 2023
- First submitted
- 29 Aug 2022
- Last updated
- 18 Jan 2023
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Lactobacilli Strains as Adjuvant Therapy in the Management of Irritable Bowel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05523427
- Acronym / sponsor ID
- CCMRE-phA-22-11
- Keywords
- IBS, IBS-D, Abdominal pain, Abdominal distention, Probiotic, Lactobacilli, Mucus, L. plantarum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MosulUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 31 Aug 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.
Studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant IBS
Detailed description
Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI) disorder that places an enormous burden on resource-challenged healthcare systems. Although many drugs have been advocated in the treatment of IBS, including psychotropic agents, antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". In IBS, a decrease in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria species (a family of pathogens), has been described in IBS studies. Therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment of IBS | No intervention | –Mebeverine 135 mg Sulpiride 25 mg Simethicone 200 mg They were administered in a single capsule, three time daily before meals. |
| Probiotics + Standard treatment of IBS | Experimental | Dietary Supplement: Two probiotic strains (L. plantarum and L. acidophilus)A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 16-55
- Both genders
- Patients diagnosed clinically with IBS based on Rome's criteria
- IBS-Diarrhea only with pain \& distention
- Duration of symptoms 6 months
Key exclusion criteria (9 listed)
- Age > 55
- Celiac disease
- Inflammatory bowel disease (ulcerative colitis \& Crohn's)
- Thyroid disease
- Colonic CA
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 |
|---|---|---|
| Two probiotic strains (L. plantarum and L. acidophilus)A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS. | Dietary supplement | Probiotics + Standard treatment of IBS |
Primary outcome
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline.
Time frame: Three months
The change in severity of abdominal pain and distention, frequency of bowel motion, satisfaction with bowel habits, and IBS-related quality of life (QoL).
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 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two probiotic strains (L. plantarum and L. acidophilus) in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by University of Mosul at 1 site in Iraq.
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 9 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 Jan 2023. 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 Iraq. 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?
The change in bowel habits (based on the IBS-SSS) after treatment with a multi-strain probiotic or standard treatment, and compared with baseline. (time frame: Three months). 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 Jan 2023.