IBSNCT03482765
A Study of Probiotics in IBS Subjects
A study testing Probiotic 1 and Probiotic 2 in people with IBS, run by Vedic Lifesciences Pvt. Ltd. at 12 sites in India.
Trial summary
For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain. The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS
- What is being tested?
- Probiotic 1 and Probiotic 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 12 sitesIndia
- Study dates
- 30 Mar 2018to 30 Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Literate (as defined by the basic capability to read and understand in the languages approved for the study), male and female subjects in age range of 18-70 years.
- Presence of Rome IV diagnostic criteria for IBS.
Who cannot join
- Anemic subjects with Hb < 10 g/dl.
- Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).
- Subjects with a history of surgical resection of the stomach, small intestine or large intestine.
- Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
- Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.
- Subjects with a history of any diet-based intolerance (gluten or lactose intolerance).
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- Subjects with a history of drug or alcohol abuse within the past 6 months.
- Subjects with a history of or complications from malignant tumors.
- Subjects with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- Subjects with uncontrolled hypertension (≥140/90 mm Hg).
- Subjects with complications from serious cardiovascular diseases, respiratory diseases, endocrinological and gynecological disorder, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
- Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- Subjects with a history of dysmenorrhea.
- Subjects with any unstable medical conditions.
- Subjects with uncontrolled Type II diabetes mellitus.
- Subjects with a history of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
- Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
- Subjects with any medical condition or a history of abdominal surgery that is deemed exclusionary by the qualified investigator.
- Subjects with an active eating disorder.
- Subjects who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
- Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) or an antibiotic within 4 weeks prior to screening.
- Subjects who have used IBS specific treatments within 4 weeks prior to screening.
- Subjects who currently consume greater than 2 standard alcoholic drinks per day from past 3 months.
- Subjects who smoke ≥ 1 cigarette per day. Occasional (Non-daily) smokers will be allowed.
- Subjects who have participated in a clinical research trial within 30 days prior to randomization.
- Subjects with an allergy or sensitivity to the probiotic products.
- Subjects who are cognitively impaired and/or who are unable to give an informed consent.
- Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the subjects' ability to complete the study or its measures or which may pose significant risk to the subject.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Apex Gastro Clinic
Ahmedabad, Gujarat, 380013
Gastrocare & Liver Clinic
Ahmedabad, Gujarat, 380015
The Gut Clinic
Mumbai, Maharashtra, 400012
Vazifdar Clinic
Mumbai, Maharashtra, 400055
Stress Test Clinic
Mumbai, Maharashtra, 400059
Shantaee Nursing Home
Mumbai, Maharashtra, 400067
Dr Sanjeev Khanna's Clinic
Mumbai, Maharashtra, 400069
Ameeta Nursing home
Mumbai, Maharashtra, 400071
Lancelot Kidney and GI Center
Mumbai, Maharashtra, 400092
Kshirsagar Nursing Home
Mumbai, Maharashtra, 400602
Samarth Clinic
Navi Mumbai, Maharashtra, 400703
Sampada Hospital
Thane, Maharashtra, 400601
About this study
Official title: A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects
For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.
The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.
Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.
Read the detailed description
This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.
- Conditions
- IBS
- Being tested
- Probiotic 1, Probiotic 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic 1Dietary supplement
Also called Bifidobacterium lactis
The product under investigation is a unique probiotic.
Probiotic 2Dietary supplement
Also called Lactobacillus acidophilus
The product under investigation is a unique probiotic.
PlaceboOther
Microcrystalline Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Probiotic 1 | Experimental | Probiotic 1: A dietary probiotic supplement which contains Bifidobacterium lactis. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. Receives: Dietary Supplement: Probiotic 1 |
| Probiotic 2 | Experimental | Probiotic 2: A dietary probiotic supplement which contains Lactobacillus acidophilus. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. Receives: Dietary Supplement: Probiotic 2 |
| Placebo | Placebo comparator | The Placebo contains MCC. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal pain severity
The change at Day 42 will be assessed by subject dairy.
Measured: 42 days
Secondary outcomes (5)
Change in abdominal pain severity
The change at Day 21 will be assessed by subject dairy
Measured: Day 21
Change in IBS symptoms
The change at Day 42 will be compared to baseline
Measured: Day 42
Change in stool consistency
The change at Day 42 will be compared to baseline by specific questionnaire
Measured: Day 42
Change in Quality of Life
The change at Day 42 will be compared to baseline by specific questionnaire
Measured: Day 42
Change in daily number of stools
The change at Day 42 will be compared to baseline
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start30 Mar 2018
- Primary completion14 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBSStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shalini Srivastava, M.D., Study director, Vedic Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482765
- Sponsor's protocol ID
- UAS/170901/PB/IBS
- Status last verified
- Jul 2019
- First submitted
- 22 Feb 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Probiotics (UABla-12™ and DDS®-1) on Digestive Health in IBS Subjects
- ClinicalTrials.gov ID
- NCT03482765
- Acronym / sponsor ID
- UAS/170901/PB/IBS
- Conditions
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Mar 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.
For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.
The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related quality of life, stool form and consistency and on mental status.
Thus providing an effective objective in improving the gut health and symptomatic relief in IBS patients.
Detailed description
This study aims to determine the effect of probiotics, as the investigational products (IPs) in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C, D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a multi-center, double-blind, parallel group, placebo-controlled randomized trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 | Experimental | Dietary Supplement: Probiotic 1Probiotic 1: A dietary probiotic supplement which contains Bifidobacterium lactis. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. |
| Probiotic 2 | Experimental | Dietary Supplement: Probiotic 2Probiotic 2: A dietary probiotic supplement which contains Lactobacillus acidophilus. Dose: > 10 billion CFU, Frequency: 1 capsule/day, duration: 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboThe Placebo contains MCC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Literate (as defined by the basic capability to read and understand in the languages approved for the study), male and female subjects in age range of 18-70 years.
- Presence of Rome IV diagnostic criteria for IBS.
Key exclusion criteria (28 listed)
- Anemic subjects with Hb < 10 g/dl.
- Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).
- Subjects with a history of surgical resection of the stomach, small intestine or large intestine.
- Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
- Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.
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 |
|---|---|---|
| Probiotic 1Also: Bifidobacterium lactisThe product under investigation is a unique probiotic. | Dietary supplement | Probiotic 1 |
| Probiotic 2Also: Lactobacillus acidophilusThe product under investigation is a unique probiotic. | Dietary supplement | Probiotic 2 |
| PlaceboMicrocrystalline Cellulose | Other | Placebo |
Primary outcome
Change in abdominal pain severity
Time frame: 42 days
The change at Day 42 will be assessed by subject dairy.
5 secondary outcomes
Change in abdominal pain severity
Time frame: Day 21
Change in IBS symptoms
Time frame: Day 42
Change in stool consistency
Time frame: Day 42
Change in Quality of Life
Time frame: Day 42
Change in daily number of stools
Time frame: Day 42
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 Jul 2019.
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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.
Shalini Srivastava, M.D. study director
Vedic Lifesciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic 1 and Probiotic 2 in people with IBS, run by Vedic Lifesciences Pvt. Ltd. at 12 sites 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 2 inclusion and 28 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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. Some participants in this study may receive a placebo. 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 abdominal pain severity (time frame: 42 days). 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 Jul 2019.