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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
314
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.
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.
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.
Apex Gastro Clinic and Hospital,
Ahmedabad, Gujarat, India
SN Gastro and Liver Clinic
Ahmedabad, Gujarat, India
Ahmedabad Gastro Associates,
Ahmedabad, Gujarat, India
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.
Time frame: Day 0, Day 56
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.
Time frame: 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.
Time frame: 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.
Time frame: Screening, Day 0, Day 28 and Day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aman Hospital and research center
Vadodara, Gujarat, India
My Health Clinic,
Mumbai, Maharashtra, India
Dr. Khanna Clinic,
Mumbai, Maharashtra, India
Stress Test Clinic
Mumbai, Maharashtra, India
Samarth Digestive Disease Centre
Mumbai, Maharashtra, India
Rahate Surgical Hospital,
Nagpur, Maharashtra, India
Ashirwad Hospital And Research Centre,
Ulhasnagar, Maharashtra, India
...and 2 more locations
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.
Time frame: 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.
Time frame: Day 0, Day 28 and Day 56