Irritable Bowel Syndrome With DiarrheaNCT04950296
To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
A study testing Group I: L. plantarum UALp-05TM,, Group II: L. plantarum UALp-05TM, and Microcrystalline cellulose in people with Irritable Bowel Syndrome With Diarrhea, run by Vedic Lifesciences Pvt. Ltd. at 12 sites in India.
Trial summary
Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Group I: L. plantarum UALp-05TM,, Group II: L. plantarum UALp-05TM, and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 12 sitesIndia
- Study dates
- 16 Sep 2021to 5 May 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 70 years.
- Participants with Irritable bowel syndrome (IBS) as per Rome IV IBS criteria:
- Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- Related to defecation (Maybe increased or decreased by defecation)
- Associated with a change in the frequency of stool (increase in frequency)
- Associated with a change in the form (appearance) of stool
Show all 17Show fewer
- History of abnormal bowel movements, which are predominantly diarrhea (more than one-fourth (25%) of bowel movements with BSS Types 6-7 and less than one-fourth (25%) with BSS Types 1-2) in the last one month prior to screening.
- Average APS-NRS score of ≥ 6 for last 3 months prior to screening visit.
- Fasting blood glucose levels ≤ 125 mg/dL (6.94 mmol/l).
- Hemoglobin ≥ 10 g/dL.
- Able to comply and perform the procedures requested by the protocol (consumption of study medications, filling scheduled eDiary for health updates, biological sample collection procedures and study visit schedule).
- Participants with access to western toilet facilities.
- Participants with non-vegetarian dietary preferences (Note: Non-vegetarian food will be defined as food derived from animals, birds, fish, shell-fish, etc)
- Participants consuming non-vegetarian food for at least 2 times in a week.
- SpO2 ≥ 96% as assessed by fingertip pulse oximetry
- Participants who are sufficiently literate to understand the essence of the study, are informed about the purpose of the study, and understand their rights.
- Participants who are able to give written informed consent and are willing to participate in the study.
Who cannot join
- Participants not meeting IBS-D diagnostic criteria (i.e. IBS-Constipation, Mixed or Unclassified).
- Uncontrolled abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 μIU/mL.
- Uncontrolled Type II DM (Controlled Type II diabetics can be included upon investigator's discretion).
- Type I diabetes.
- Uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg.
- Use of probiotics and/or prebiotics (In the form of supplements) within the last 4 weeks prior to screening.
Show all 24Show fewer
- Use of medicines (Prescription, OTC, etc), health supplements or herbal medicines expected to promote gut health and alleviate IBS related complications within the last four 4 months prior to screening.
- Established diagnosis of Helicobacter pylori infection in last 3 months prior to screening.
- History of surgical resection of the stomach, small intestine or large intestine.
- Participants with acute gastroenteritis.
- History or complications of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or ischemic colitis.
- Participants with complications from infectious enteritis.
- History of any diet-based intolerance (gluten or lactose intolerance).
- History of or complications from malignant tumors.
- History of any significant neurological or psychiatric condition which may affect study participation or inference of study outcomes.
- Consumption of psychotropic agents in the last 1 year prior to screening.
- History (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco.
- Participation in other clinical trials in last 90 days prior to screening.
- Participants with heavy alcohol consumption, defined as:
- For men: More than 14 standard alcoholic drinks (SAD)/week or more than 4 SAD in a day.
- For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
- Participants who have a clinically active state of systemic illness, which may include but is not limited to cardiovascular, endocrine, immune, respiratory, hepatobiliary, kidney and genitourinary, neuropsychiatric, and gastrointestinal system. To be ruled out by physician based on prior history and physical examination.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Apex Gastro Clinic and Hospital,
Ahmedabad, Gujarat, 380013.
SN Gastro and Liver Clinic
Ahmedabad, Gujarat, 380054
Ahmedabad Gastro Associates,
Ahmedabad, Gujarat, 380061
My Health Clinic,
Mumbai, Maharashtra, 400059.
Dr. Khanna Clinic,
Mumbai, Maharashtra, 400059
Stress Test Clinic
Mumbai, Maharashtra, 400059
Samarth Digestive Disease Centre
Mumbai, Maharashtra, 400705,
Rahate Surgical Hospital,
Nagpur, Maharashtra, 440008.
Ashirwad Hospital And Research Centre,
Ulhasnagar, Maharashtra, 421004
Aman Hospital and research center
Vadodara, Gujarat, -390021.
Shubham Sudbhawana Superspeciality Hospital,
Varanasi, Uttar Pradesh, 221005.
Khannas Clinic
Varanasi, Uttar Pradesh, 221010
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.
Read the detailed description
Several strains of Lactobacillus genus have previously been assessed in patients with IBS in multiple randomized controlled trials, demonstrating the efficacy of these strains in reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain severity, normalizing diarrhea predominant stool type and subsequently improving quality of life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of 10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of 8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Group I: L. plantarum UALp-05TM,, Group II: L. plantarum UALp-05TM,, Microcrystalline cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I: L. plantarum UALp-05TM,Other
Also called Active
One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
Group II: L. plantarum UALp-05TM,Other
Also called Active
One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
Microcrystalline celluloseOther
Also called Placebo
One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
| Study group | Role | What they receive |
|---|---|---|
| Group I: L. plantarum UALp-05TM, | Active comparator | One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. Receives: Other: Group I: L. plantarum UALp-05TM, |
| Group II: L. plantarum UALp-05TM, | Active comparator | One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. Receives: Other: Group II: L. plantarum UALp-05TM, |
| Microcrystalline Cellulose | Placebo comparator | One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. Receives: Other: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Symptom Severity Scale
To evaluate the effect of IP consumption on change in Irritable Bowel Syndrome Symptom Severity Scale total score on day 56 from baseline (Day 0) in comparison to placebo.
A score on a scale, include 0 to 100 pointer scale the minimum score is the better outcome and maximum values is worse outcome.
Measured: Day 0, Day 56
Secondary outcomes (5)
Irritable Bowel Syndrome Symptom Severity Scale
To evaluate the effect of Investigational Product on global assessment of Irritable Bowel Syndrome symptoms, as assessed by the change in Irritable Bowel Syndrome Symptom Severity Scale total score on day 28 from baseline (day 0) in comparison to placebo. A score on a scale, include 0 to 100 pointer scale the minimum score is the better outcome and maximum values is worse outcome.
Measured: Day 28
Abdominal Pain Severity Numeric Rating Scale
To evaluate the effect of IP on abdominal pain severity (11-point scale), as assessed by the change in Abdominal Pain Severity Numeric Rating Scale score on day 56 from baseline (day 0) in comparison to placebo. A score on a scale, include 0 to 10 pointer scale the minimum score is the better outcome and maximum values is worse outcome.
Measured: Screening, Day 0, Day 28 and Day 56
Bristol Stool Scale
To evaluate the effect of IP on percentage of study population achieving normal stool consistency, as assessed by Bristol Stool Scale on day 56 from baseline (day 0) in comparison to placebo. Bristol Stool Scale (BSS), a validated ordinal scale of stool types ranging from 1 through 7, with types 1-2 and 6-7, in conjunction with other symptoms, indicative of constipation and diarrhea, respectively. Types 3-5 are generally considered to be the most normal stool form and are the modal stool forms in cross-sectional surveys of healthy adults.
Measured: Screening, Day 0, Day 28 and Day 56
Irritable Bowel Syndrome Symptom Severity Scale percent responder
To evaluate the effect of IP on percent responders defined by clinically significant Irritable Bowel Syndrome Symptom Severity Scale total score improvement on day 56 in comparison to placebo.
A score on a scale, include 0 to 100 pointer scale the minimum score is the better outcome and maximum values is worse outcome.
Measured: Day 56
Irritable Bowel Syndrome -Quality of Life
To evaluate the effect of IP on quality of life as assessed by the change in Irritable Bowel Syndrome -Quality of Life score on day 56 from baseline (day 0) in comparison to placebo.
34 set of Questionnaire indication following score 1=Not at all, 2=Slightly, 3=Moderately, 4=Quite a bit, 5=A great deal, the minimum score is the better outcome and maximum values is worse outcome.
Measured: Day 0, Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start16 Sep 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ramesh Dargad, Principal investigator, Stress test clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950296
- Sponsor's protocol ID
- UAS201003/LPLANTARUMUALP05IBS
- Status last verified
- Jan 2022
- First submitted
- 16 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04950296
- Acronym / sponsor ID
- UAS201003/LPLANTARUMUALP05IBS
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 6 Jul 2021 (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.
Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI tract that has been studied in numerous GI clinical studies, including for IBS.In the present study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in individuals with IBS-D.
Detailed description
Several strains of Lactobacillus genus have previously been assessed in patients with IBS in multiple randomized controlled trials, demonstrating the efficacy of these strains in reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain severity, normalizing diarrhea predominant stool type and subsequently improving quality of life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of 10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of 8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, placebo-controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| Group I: L. plantarum UALp-05TM, | Active comparator | Other: Group I: L. plantarum UALp-05TM,One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. |
| Group II: L. plantarum UALp-05TM, | Active comparator | Other: Group II: L. plantarum UALp-05TM,One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. |
| Microcrystalline Cellulose | Placebo comparator | Other: Microcrystalline celluloseOne capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females aged 18 to 70 years.
- Participants with Irritable bowel syndrome (IBS) as per Rome IV IBS criteria:
- Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- History of abnormal bowel movements, which are predominantly diarrhea (more than one-fourth (25%) of bowel movements with BSS Types 6-7 and less than one-fourth (25%) with BSS Types 1-2) in the last one month prior to screening.
- Average APS-NRS score of ≥ 6 for last 3 months prior to screening visit.
Key exclusion criteria (24 listed)
- Participants not meeting IBS-D diagnostic criteria (i.e. IBS-Constipation, Mixed or Unclassified).
- Uncontrolled abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 μIU/mL.
- Uncontrolled Type II DM (Controlled Type II diabetics can be included upon investigator's discretion).
- Type I diabetes.
- Uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg.
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 |
|---|---|---|
| Group I: L. plantarum UALp-05TM,Also: ActiveOne capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. | Other | Group I: L. plantarum UALp-05TM, |
| Group II: L. plantarum UALp-05TM,Also: ActiveOne capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. | Other | Group II: L. plantarum UALp-05TM, |
| Microcrystalline celluloseAlso: PlaceboOne capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner. | Other | Microcrystalline Cellulose |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Scale
Time frame: Day 0, Day 56
To evaluate the effect of IP consumption on change in Irritable Bowel Syndrome Symptom Severity Scale total score on day 56 from baseline (Day 0) in comparison to placebo. A score on a scale, include 0 to 100 pointer scale the minimum score is the better outcome and maximum values is worse outcome.
5 secondary outcomes
Irritable Bowel Syndrome Symptom Severity Scale
Time frame: Day 28
Abdominal Pain Severity Numeric Rating Scale
Time frame: Screening, Day 0, Day 28 and Day 56
Bristol Stool Scale
Time frame: Screening, Day 0, Day 28 and Day 56
Irritable Bowel Syndrome Symptom Severity Scale percent responder
Time frame: Day 56
Irritable Bowel Syndrome -Quality of Life
Time frame: Day 0, Day 28 and Day 56
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 11 Jul 2022.
Related trials for Irritable Bowel Syndrome With Diarrhea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
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.
Dr. Ramesh Dargad principal investigator
Stress test clinic
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I: L. plantarum UALp-05TM,, Group II: L. plantarum UALp-05TM, and Microcrystalline cellulose in people with Irritable Bowel Syndrome With Diarrhea, 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 17 inclusion and 24 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 11 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 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?
Irritable Bowel Syndrome Symptom Severity Scale (time frame: Day 0, Day 56). 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 11 Jul 2022.