Functional ConstipationNCT06730594
A Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
A study testing VL-BK-02 (25 billion CFU/Capsule) in people with Functional Constipation, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
Trial summary
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with Functional constipation as compared to a placebo. Approximately 205 individuals aged between 18 and 60 years will be screened. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- VL-BK-02 (25 billion CFU/Capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 6 sitesIndia
- Study dates
- 25 Jan 2025to 14 Mar 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals agreed to the signed and dated informed consent form.
- Male and female individuals of age between 18 to 60 years (both values included)
- Individuals who meet Rome IV diagnostic criteria for functional constipation as indicated by the criteria fulfilled for the last 3 months with symptoms onset at least 6 months prior to diagnosis:
- Must include two or more of the following criteria:
- Fewer than three SBMs per week
- Straining during more than ¼ (25%) of defecations
Show all 13Show fewer
- Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- Sensation of incomplete evacuation more than ¼ (25%) of defecations
- Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
- Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome
- Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
- Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
- Individuals with fewer than three CSBMs per week.
Who cannot join
- Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
- Individuals with anorectal pathology
- Individuals with history of gastrointestinal surgery including appendisectomy.
- Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator.
- Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
- Current pharmacological treatment related to constipation (e.g. prosecretory agents, antidepressants, antispasmodics, enterokinetic)
Show all 27Show fewer
- Individuals consuming dietary treatment (e.g. synbiotics, herbal extracts, fibers) or taking other therapies for treating constipation (e.g. cognitive behavior therapy, acupuncture, biofeedback, complementary and alternative Medicine) within 1 month prior to screening.
- Use of antibiotics within 1 month prior to screening.
- Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening
- Opioids-induced constipation.
- Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT- antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month prior to screening.
- Immuno-compromised participants.
- Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
- History of cancer .
- Individuals with known history of diabetes mellitus and are on medication for the same.
- Individuals suffereing from Diabetic gastroparesis.
- History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- Individuals with impaired thyroid function reported by TSH less than 0.4 mIU/L and more than 5 mIU/L will be excluded. However, individuals on a stable dose of medication for past 6 months and within the aforementioned range, can be considered.
- Psychiatric or behavioral disorders as judged by the Investigator
- Individuals with known food allergy.
- Individuals with eating disorders (e.g., anorexia, bulimia)
- Pregnancy or lactation
- Known allergic reactions to any components of the probiotics or placebo.
- Individuals participating in other interventional study within 90 days prior to screening.
- Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment.
- Current Smokers.
- Individuals with more than 14 SBMs per week.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
AK Superspeciality Clinic
Pune, Maharashtra, 411014
Gastrohub Hospital
Pune, Maharashtra, 411027
Lifeline multispecialty Hospital
Pune, Maharashtra, 412101
Care Multispecialty Hospital
Pune, Maharashtra, 412207
Anand Multispeciality Hospital
Vadodara, Gujarat, 390016
Krishna Hospital
Varanasi, Uttar Pradesh, 221005
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with Functional constipation as compared to a placebo. Approximately 205 individuals aged between 18 and 60 years will be screened.
Considering a screen failure of 20%, approximately 164 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 126 completed participants i.e. 63 partcipants in each study arm after accounting for a dropout/withdrawal rate of 23% at the end of the study. The intervention duration for all the study participants will be 56 days with follow up of upto 84 days. The study flow chart given below indicates the time points at which safety and efficacy assessments will be conducted
- Conditions
- Functional Constipation
- Being tested
- VL-BK-02 (25 billion CFU/Capsule), Placebo (Microcrystalline Cellulose - 375 mg/capsule)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VL-BK-02 (25 billion CFU/Capsule)Dietary supplement
One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)
Placebo (Microcrystalline Cellulose - 375 mg/capsule)Dietary supplement
One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| VL-BK-02 (25 billion CFU/Capsule) | Experimental | One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks) Receives: Dietary Supplement: VL-BK-02 (25 billion CFU/Capsule) |
| Placebo (Microcrystalline Cellulose - 375 mg/capsule) | Placebo comparator | One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks) Receives: Dietary Supplement: Placebo (Microcrystalline Cellulose - 375 mg/capsule) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs)
Severe constipation is defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥ 3.0 (CIC; 5-point scale) CSBM has emerged as an attractive symptom-specific primary endpoint for constipation trials, as it integrates the objective, quantitative sign of stool frequency and the subjective, qualitative symptom of sensation of complete defecation
Measured: per week from baseline to the end of study visit.
Secondary outcomes (6)
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.
The BSFS is a commonly used ordinal stool-type scale in clinical research and practice that goes from the hardest (type 1) to the softest (type 7). Abnormally hard stools (and in conjunction with other symptoms indicative of constipation) are referred to as types 1 and 2. On the other hand, types 6 and 7 are characterized by unusually loose or watery stools together with other symptoms that point to diarrhea. Stool forms 3-5 are regarded as the most "normal.
Measured: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM) from baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
Chronic constipation is a common, self-reported, symptom-based disorder, which can significantly impact an individual's health-related quality of life The 12-item questionnaire is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe', and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.
Measured: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)
The PAC-QOL questionnaire is subcategorized into 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Response choice is a Likert scale from 0 to 4.Higher scores mean higher negative effects on quality of life. Items
Measured: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
To assess the effect of Investigational product (IP) in comparison to baseline and placebo Percentage responders are defined as the number of participants with an increase by 1 or more frequencies of CSBM from baseline to the end of intervention.
Based on EMA guidelines, a CSBM weekly responder will be defined as a participant who experienced more than or equal to 3 CSBMs per week and an increase of ≥ 1 CSBM per week (compared to the baseline).46,47 A "sustained response" will be defined as fulfilling these criteria for the last 4 weeks of treatment.
Measured: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo in Gut microbiome (alpha and beta diversity) from baseline to end of intervention.
Stool samples will be collected from the participants on Day 0 and Day 56. A window period of ± 3 days will be provided for stool sample collection. Participants will be provided with a stool sample collection kit with sample collection instructions on screening day and day 28. Stool samples will be collected from participants's homes or on site at Day 0 and Day 56. The samples will be further stored for future analysis of metagenome NGS sequencing. Stool samples will be collected from the participants and shipped to the central lab in gel ice pack. Stool samples for NGS will be stored at -80 degrees until shipped to the central lab
Measured: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo Difference in the usage of rescue medication throughout the study duration as compared to placebo
Bowel movement within 24 hours of consuming the rescue medication will not be considered as an SBM or a CSBM
Measured: through study completion, an average of Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start25 Jan 2025
- Primary completion14 Mar 2026
- Study completion14 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies 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
- Model description
- Parallel Assignment A randomized, double-blind, two-arm, placebo-controlled clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730594
- Sponsor's protocol ID
- KE/240401/BK+/FC V.2
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to Assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults With Functional Constipation
- ClinicalTrials.gov ID
- NCT06730594
- Acronym / sponsor ID
- KE/240401/BK+/FC V.2
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 14 Mar 2026 (actual)
- First posted
- 12 Dec 2024 (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.
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with Functional constipation as compared to a placebo. Approximately 205 individuals aged between 18 and 60 years will be screened.
Considering a screen failure of 20%, approximately 164 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 126 completed participants i.e. 63 partcipants in each study arm after accounting for a dropout/withdrawal rate of 23% at the end of the study. The intervention duration for all the study participants will be 56 days with follow up of upto 84 days. The study flow chart given below indicates the time points at which safety and efficacy assessments will be conducted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment A randomized, double-blind, two-arm, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| VL-BK-02 (25 billion CFU/Capsule) | Experimental | Dietary Supplement: VL-BK-02 (25 billion CFU/Capsule)One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks) |
| Placebo (Microcrystalline Cellulose - 375 mg/capsule) | Placebo comparator | Dietary Supplement: Placebo (Microcrystalline Cellulose - 375 mg/capsule)One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Individuals agreed to the signed and dated informed consent form.
- Male and female individuals of age between 18 to 60 years (both values included)
- Individuals who meet Rome IV diagnostic criteria for functional constipation as indicated by the criteria fulfilled for the last 3 months with symptoms onset at least 6 months prior to diagnosis:
- Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
- Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
Key exclusion criteria (27 listed)
- Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
- Individuals with anorectal pathology
- Individuals with history of gastrointestinal surgery including appendisectomy.
- Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator.
- Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
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 |
|---|---|---|
| VL-BK-02 (25 billion CFU/Capsule)One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks) | Dietary supplement | VL-BK-02 (25 billion CFU/Capsule) |
| Placebo (Microcrystalline Cellulose - 375 mg/capsule)One capsule per day consumed orally before breakfast Duration: 84 days (12 weeks) | Dietary supplement | Placebo (Microcrystalline Cellulose - 375 mg/capsule) |
Primary outcome
To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs)
Time frame: per week from baseline to the end of study visit.
Severe constipation is defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥ 3.0 (CIC; 5-point scale) CSBM has emerged as an attractive symptom-specific primary endpoint for constipation trials, as it integrates the objective, quantitative sign of stool frequency and the subjective, qualitative symptom of sensation of complete defecation
6 secondary outcomes
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.
Time frame: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM) from baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
Time frame: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)
Time frame: Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.
To assess the effect of Investigational product (IP) in comparison to baseline and placebo Percentage responders are defined as the number of participants with an increase by 1 or more frequencies of CSBM from baseline to the end of intervention.
Time frame: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo in Gut microbiome (alpha and beta diversity) from baseline to end of intervention.
Time frame: Baseline to Day 84
To assess the effect of Investigational product (IP) in comparison to baseline and placebo Difference in the usage of rescue medication throughout the study duration as compared to placebo
Time frame: through study completion, an average of Day 84
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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
Functional Constipation
Active, not recruiting
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
Constipation, Constipation - Functional
Recruiting
Fiber Nutritional Supplement for Management of Constipation During Pregnancy
Functional Constipation (FC)
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VL-BK-02 (25 billion CFU/Capsule) in people with Functional Constipation, run by Vedic Lifesciences Pvt. Ltd. at 6 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 13 inclusion and 27 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) (time frame: per week from baseline to the end of study visit.). 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 19 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.