| CTRI Number |
CTRI/2023/10/058902 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
02/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To evaluate the effectiveness of DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti N Kulkarni |
| Designation |
Consultant- Physician |
| Affiliation |
Sanjeevini Hospital |
| Address |
Room no. 3, 761, 7th Main Road, Last Bus Stop, Mahalakshmi Layout, Bangalore, Karnataka, India-560086
Bangalore
KARNATAKA
560086
India |
| Phone |
9731600196 |
| Fax |
|
| Email |
shruti.nk666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ABHIJIT RATHI |
| Designation |
Principle Scientist |
| Affiliation |
Advanced Enzyme Technologies Ltd |
| Address |
Advanced Enzyme Technologies Ltd
‘A’ wing Sun Magnetica, 5th Floor,
LIC Service Rd, Louis Wadi,
Thane, Maharashtra 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
2225812294 |
| Fax |
|
| Email |
akrathi@advancedenzymes.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujay Gowda |
| Designation |
Head Clinical Development |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building 06, 3rd Floor, 2nd Main Rd,
Opposite To British Biologicals, Sarvobhogam Nagar, Arekere,
Bengaluru, Karnataka 560076 India Bangalore KARNATAKA
Bangalore
KARNATAKA
560076
India
Bangalore
KARNATAKA
560076
India |
| Phone |
6366241472 |
| Fax |
|
| Email |
sujay.gowda@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Advanced Enzyme Technologies Ltd
‘A’ wing Sun Magnetica, 5th Floor,
LIC Service Rd, Louis Wadi,
Thane, Maharashtra 400604
|
|
|
Primary Sponsor
|
| Name |
Advanced Enzyme Technologies Ltd |
| Address |
Advanced Enzyme Technologies Ltd
‘A’ wing Sun Magnetica, 5th Floor,
LIC Service Rd, Louis Wadi,
Thane, Maharashtra 400604
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti N Kulkarni |
Sanjeevini Hospital |
Room No. 3, 761, 7th Main Road, Last Bus Stop, Mahalakshmi Layout, Bangalore, Karnataka, India-560086
Bangalore
KARNATAKA |
9731600196
shruti.nk666@gmail.com |
| Dr Jeeva Rima S |
Sri Laxmi Hospital |
#50, Opp. to Velankani Road,
Doddathogur Village, Electronics City Post,
Bangalore 560 100 Karnataka
Bangalore
KARNATAKA |
9909712144
jeevarima@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| EC on Human Research, Sanjeevini Hospital-Institutional Ec |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age between 30 to 60 years (Both inclusive) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DigeSEB Super PB |
Dose: 400 mg capsule
Dosage form: Capsule
Frequency: Two Capsules, Twice a day
(2 capsules just after lunch + 2 capsules just after dinner)
Route of administration: Oral
|
| Comparator Agent |
Maltodextrin (Placebo) |
Dose: 400 mg capsule.
Dosage form: Capsule
Frequency: Two Capsules, Twice a day
(2 capsules just after lunch + 2 capsules just after dinner)
Route of administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Literate Male and female in equal ratio i e 18 in each group between the age of 30 to 60 years both inclusive
2 Participants determined by the PI as healthy participants with no known history of any disease or with complaints of any health aliment not prescribed with any medications and indicating good health with normal appetite normal physical and mental conditions
3 Participants willing to give written informed consent and adhere to all the requirements of this protocol
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating female.
2.Participants with BMI ≥ 30
3.Smokers and people who consume alcohol.
4.Subject having known allergy to the ingredients in the test product.
5.Known history of diabetes and hypertension.
6.Participant having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Crohn’s disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS).
7.Participant has a history of bariatric surgery at any time before the Screening Visit.
8.Participant has a history of any surgery in the past 3 months.
9.Participant has a history of lactose intolerance.
10.Participant on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems.
11.Participant currently taking laxatives or has taken laxatives within the 30 days prior to screening/ enrollment.
12.Participant currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrollment.
13.Participant currently taking or has in the past 30 days used GI related probiotics/prebiotics or any digestive enzymes [prescription or over the counter (OTC)].
14.As per discretion/ judgement of the PI, subjects suspected with any medical condition during examination at screening
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nutrient absorption (rate & concentration) in blood stream
Amino acid analysis
Triglycerides
Total Cholesterol
Glucose
|
Day 30 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Serum markers
a Insulin
b HbA1c
2 Questionnaire and Scales
a Post prandial Hunger and Satiety scale
b Gastrointestinal Symptom Questionnaire
3 Serum markers SGOT SGPT Serum creatinine blood urea nitrogen BUN total albumin and globulin
4 Microbiota analysis in an equally distributed sub population of 10 participants
5 Product tolerability
a Tolerability to investigation product
6 Rate of incidence of AE and SAEs |
1 Serum markers
a Day 30 and Day 90
b Baseline Day 30 Day 61 and Day 90
2 Questionnaire and Scales
a Day 1 Day 7 Day 15 Day 21 Day 30 Day 61 Day 67 Day 75 Day 81 and Day 90
b Day 1 Day 30 Day 61 and day 90
3 Serum markers Baseline Day 30 and Day 90
4 Microbiota analysis Day 30 and Day 90
5 Product tolerability
Day 30 and Day 90
6 Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, double blind, placebo controlled, crossover study to evaluate the effect of
DigeSEB Super PB on digestion and gastrointestinal symptoms in healthy adults. The trial will be conducted in adult male and female healthy volunteers
between the age of 30 to 60 years (both inclusive) and having body mass index ≥ 30. Participants will be on study for a
max. of 3 Months including wash out period. The study aims to evaluate the effect of
DigeSEB Super PB on the postprandial nutrient level and to evaluate safety &
tolerability of DigeSEB Super PB and its effect on gastro-intestinal symptoms
and gut microbiota in healthy adults. Statistical analysis will be
performed as listed in the protocol. The enzymes included in investigational
product derived from non-animal sources and considered safe for human
consumption. This product contains combination of enzymes (amylase, protease,
lipase, cellulase, lactase, and hemicellulase) and probiotic strains (B. coagulans, B. clausii, B. subtilis, L.
plantarum and L. casei); these
ingredients are approved by FSSAI for nutraceutical use. |