Gastrointestinal DysfunctionNCT05820737
A Study to Assess the Gut Health Effects of Heat-killed Post-biotics in Overweight and Obese Adults
A study testing EF2001 and beLP1 in people with Gastrointestinal Dysfunction, run by Vedic Lifesciences Pvt. Ltd. at 9 sites in India.
Trial summary
The present study is a randomized, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- EF2001 and beLP1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 9 sitesIndia
- Study dates
- 14 Apr 2024to 24 Mar 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female individuals with the age ≥18 and ≤45 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF - SF)
- BMI of ≥ 25 - ≤ 35 kg/m2
- Individuals with liver \& renal function test values as defined below:
- Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).
- Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).
- Individuals with ALP values ≥ 38 and ≤ 126 U/L
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- Having at least two of the following five metabolic risk factors:
- Waist circumference > 102 cm (40 inches) for men and > 88 cm (35 inches) for women
- Fasting triglycerides >150 mg/dL and < 300 mg/dl
- Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (Diastolic Blood Pressure)
- Fasting blood glucose ≥ 100 mg/ dl
- Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women)
- History of mild to moderate gastrointestinal discomfort for at least last three months
- Individuals experiencing moderate-intensity gastrointestinal symptoms, evaluated based on the combined scores of two GSRS domains (dyspeptic syndrome and bowel dysfunction), falling within the range of ≥ 15 and ≤ 29 over the past two weeks. (The highest score out of two weeks' GSRS scores will be taken into consideration for the study)
- Willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- Willing to abstain from other supplements or medication.
- Ready to give voluntary, written, informed consent to participate in the study
- No prohibited antibiotic usage within the last 30 days.
- History of stable weight over the last 6 months (<10% change)
- Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol
- Randomization Criteria:
- Two weeks of run - in period for weight stability (Weight instability defined as > 2 kg of weight gain or loss over 2 weeks of run-in period)
- GSRS scores not less than that reported at screening. (The highest score out of two weeks' GSRS scores will be taken into consideration for the study)
- Both the weekly at-home diaries for GSRS should be available
- 80% compliance to the run-in medication
Who cannot join
- Individual who smokes and consumes tobacco regularly.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Individuals diagnosed with diabetes and are on active medication
- FBG > 125 mg/dl
- Individuals diagnosed with hypertension and are on active medication.
- Individuals with uncontrolled hypertension with systolic blood pressure ≥150 and/or diastolic blood pressure ≥100 mm Hg.
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- Individuals with neurological conditions causing functional or cognitive impairments.
- Individuals with a history or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
- Individuals under use of any psychotropic medication within four weeks of screening and throughout the study
- Individual under use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to allow the subject to wash off the antibiotic for at least five days prior to any test visit
- Individual states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
- Individuals states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics
- Exposure to any non-registered drug product within 3 months prior to the screening visit.
- Unable/unwillingness to complete study specific diaries (digital/paper-based).
- Current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/ dietary supplement.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Individual who reports alcohol intake as average of 3 or more servings per day 18. Individuals with thyroid dysfunction as assessed by TSH ≤ 0.4 or ≥ 4.3 mIU/L.
- Individuals state they have an allergy or intolerance to any ingredient in the study product or test meal.
- Individual is deemed unsuitable for study based upon study physician assessment.
- Individual is taking part in another clinical trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
AIIMS Hospital
Dombivali, Maharashtra, 421203
Metabol
Ghātkopar, 400086
Ramesh Dargad Clinic
Mumbai, Maharashtra, 400049
Sarthak Health Clinic.
Nashik, Maharashtra, 422001
Surya Multispeciality hospita
Nashik, Maharashtra, 422003
Dr. Thakare superspeaciality clinic
Nashik, Maharashtra, 422008
Life care Hospital
Nashik, Maharashtra, 422009
Dr. KotharisDigestive andLiver care
Pune, Maharashta, 411028
Dhanwantari Hospita
Pune, 411002
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Heat-killed Post-biotics EF2001 & beLP1 in Overweight and Obese Adults
The present study is a randomized, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- EF2001, beLP1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EF2001Dietary supplement
One capsule to be consumed once a day
beLP1Dietary supplement
One capsule to be consumed once a day
PlaceboDietary supplement
One capsule to be consumed once a day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 capsule to be consumed once a day Receives: Dietary Supplement: Placebo |
| EF2001 | Active comparator | 1 capsule to be consumed once a day Receives: Dietary Supplement: EF2001 |
| beLP1 | Active comparator | 1 capsule to be consumed once a day Receives: Dietary Supplement: beLP1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.
Questions are to be rated on a Likert scale ranging from no discomfort at all (0) to very severe discomfort (3). A total score is calculated by summing the ratings provided on all questions. The questionnaire has 18 items - epigastric pain, colicky pain, dull pain, undefined pain, heartburn, acid regurgitation, sucking sensation, nausea and vomiting, borborygmus, abdominal distension, eructation, increased flatus, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation and feeling of incomplete evacuation
Measured: Day 42 and Day 84
Secondary outcomes (12)
To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..
The overall body composition (Lean Body Mass, Body Fat percent, Fat Free Mass, android and gynoid fat) will be evaluated using Dual Energy X-ray Absorptiometry scan (DEXA).
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP).
The amount of the LBP will be calculated based on the standard curve. A study demonstrated an average of 7.8 μg/mL of LBP in obese individuals and 6 μg/mL in normal weight individuals.
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
HOMA-IR = (Fasting glucose × Insulin levels) ÷ 40 In a clinical study, subjects without metabolic syndrome exhibited a HOMA-IR value of 2.39, whereas obese subjects showed a higher HOMA-IR of 4.04.
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ
In the current study, the impact of the heat killed postbiotics will be evaluated in enhancing the immune-modulatory characteristics in individuals under metabolic stress
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.
IL-6 may be considered as a significant prognostic indicator of risk of any metabolic disorder.
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Inflammation by assessing the levels of Tumor necrosis factor -alpha (TNF - α)
TNF levels were elevated in adipose tissue in obese and insulin-resistant rodents and suggested that TNF had a role in mediating insulin resistance
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
The Lipid Profile will be performed on Roche cobas, Desirable cholesterol level is < 5.17 mmol/L (< 200 mg/dL). Desirable HDL level is > 1.68 mmol/L (> 65 mg/dL) in females \& > 1.45 mmol/L (> 55 mg/dL) in males. Normal range of triglycerides is < 1.70 mmol/L (< 150 mg/dL)
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.
Quality of life using Digestive Associated Quality of Life Questionnaire., The total score represents the sum of the responses to the 9 statements with possible scores ranging from 0 to 9. A higher score indicates a lower (worse) digestion-associated QOL.
Measured: Day 42 and Day 84
To assess the impact of the IP on change in the following parameters baseline on Short Chain Fatty Acids (SCFA)
Short Chain Fatty Acids (SCFA)
Measured: Day 84
To assess the impact of the IP on change in the following parameters from baseline on Humoral response as assessed by Th1/Th2 in plasma.
Th1 cells secrete the cytokine interferon-gamma and activate inflammatory pathways mainly via macrophage activation .Th2 cells secrete cytokines interleukin-4 and -5 that upregulate antibody formation via B cells, mast cells, eosinophils, and other pathways. Th1 and Th2 cells can cross-inhibit each other
Measured: Day 84
To assess the impact of the IP on change in the following parameters from baseline on Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.
Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start14 Apr 2024
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies 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, parallel group, placebo controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 155 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
- NCT05820737
- Sponsor's protocol ID
- BR/221101/EFLP/GH
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manoharan RK, Han KI, Lee Y, Baek S, Moon E, Park YB, Cho J, Chaudhary J, Shin HD. Gut health and microbiome modulation by the heat-killed postbiotic beLP1(R) in adults with excess weight: a randomized, placebo-controlled trial. Front Nutr. 2026 Sep 17;13:1919277. doi: 10.3389/fnut.2026.1919277. eCollection 2026.
PubMed 42824179
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Gut Health Effects of Heat-killed Post-biotics EF2001 & beLP1 in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT05820737
- Acronym / sponsor ID
- BR/221101/EFLP/GH
- Conditions
- Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 20 Apr 2023 (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, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, parallel group, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule to be consumed once a day |
| EF2001 | Active comparator | Dietary Supplement: EF20011 capsule to be consumed once a day |
| beLP1 | Active comparator | Dietary Supplement: beLP11 capsule to be consumed once a day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Male and female individuals with the age ≥18 and ≤45 years with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF - SF)
- BMI of ≥ 25 - ≤ 35 kg/m2
- Individuals with liver \& renal function test values as defined below:
- Having at least two of the following five metabolic risk factors:
- History of mild to moderate gastrointestinal discomfort for at least last three months
Key exclusion criteria (20 listed)
- Individual who smokes and consumes tobacco regularly.
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Individuals with neurological conditions causing functional or cognitive impairments.
- Individual under use of antibiotics or signs of active systemic infection at the time of screening. Treatment visits will be rescheduled to allow the subject to wash off the antibiotic for at least five days prior to any test visit
- Individual states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study. Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes.
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 |
|---|---|---|
| EF2001One capsule to be consumed once a day | Dietary supplement | EF2001 |
| beLP1One capsule to be consumed once a day | Dietary supplement | beLP1 |
| PlaceboOne capsule to be consumed once a day | Dietary supplement | Placebo |
Primary outcome
To assess efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline.
Time frame: Day 42 and Day 84
Questions are to be rated on a Likert scale ranging from no discomfort at all (0) to very severe discomfort (3). A total score is calculated by summing the ratings provided on all questions. The questionnaire has 18 items - epigastric pain, colicky pain, dull pain, undefined pain, heartburn, acid regurgitation, sucking sensation, nausea and vomiting, borborygmus, abdominal distension, eructation, increased flatus, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation and feeling of incomplete evacuation
12 secondary outcomes
To assess the impact of the IP from baseline as compared to placebo on Body Composition using Dual Energy X-ray Absorptiometry scan (DEXA)..
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to Gut permeability by assessing the levels of Lipopolysaccharide Binding Protein (LBP).
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Homeostasis Model Assessment-Estimated Insulin Resistance (HOMA-IR)
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Immunomodulation using INF-γ
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Cytokine levels like IL-6.
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Inflammation by assessing the levels of Tumor necrosis factor -alpha (TNF - α)
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Lipid profile: Total cholesterol, Triglyceride, HDL, LDL.
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline on Perceived Stress Scale (PSS)
Time frame: Day 42 and Day 84
To assess the impact of the IP from baseline as compared to placebo on Quality of life using Digestive Associated Quality of Life Questionnaire.
Time frame: Day 42 and Day 84
To assess the impact of the IP on change in the following parameters baseline on Short Chain Fatty Acids (SCFA)
Time frame: Day 84
To assess the impact of the IP on change in the following parameters from baseline on Humoral response as assessed by Th1/Th2 in plasma.
Time frame: Day 84
To assess the impact of the IP on change in the following parameters from baseline on Gut microbiome diversity using metagenome NGS sequencing of the fecal samples.
Time frame: 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 25 Jun 2025.
- Derived from this study: PubMed 42824179Manoharan RK, Han KI, Lee Y, Baek S, Moon E, Park YB, Cho J, Chaudhary J, Shin HD. Gut health and microbiome modulation by the heat-killed postbiotic beLP1(R) in adults with excess weight: a randomized, placebo-controlled trial. Front Nutr. 2026 Sep 17;13:1919277. doi: 10.3389/fnut.2026.1919277. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EF2001 and beLP1 in people with Gastrointestinal Dysfunction, run by Vedic Lifesciences Pvt. Ltd. at 9 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 25 inclusion and 20 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 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 efficacy of the Post-biotics on Gastrointestinal Symptom Rating Scale (GSRS) from baseline. (time frame: Day 42 and Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820737, which also lists 1 linked publication.
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 25 Jun 2025.