| CTRI Number |
CTRI/2024/01/062024 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of probiotic in the management of nonalcoholic fatty liver disease |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the efficacy and safety of UB-ABC in adults with nonalcoholic fatty liver disease (NAFLD)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IHS/UBL/01/23 Version 1 dt 21-04-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Talekar |
| Designation |
Physician and consultant |
| Affiliation |
Anupama Research Foundation |
| Address |
A Wing, Room no.2, Kadsiddheshwar Building No.3
Shriram Tekadi Path
T.J. Road
Sewree
Mumbai
Mumbai
MAHARASHTRA
400015
India |
| Phone |
|
| Fax |
|
| Email |
mktalekar78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayanthi Neelamraju |
| Designation |
Head-Scientific Affairs |
| Affiliation |
Unique Biotech Limited |
| Address |
Plot no.2, Phase-II, M.N. Park, Kolthur village, Shameerpet mandal, Medchal Malkajgiri dist
Hyderabad
Hyderabad
TELANGANA
500101
India |
| Phone |
402375134647 |
| Fax |
|
| Email |
jayanthi@uniquebiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJayanthi Neelamraju |
| Designation |
Head-Scientific Affairs |
| Affiliation |
Unique Biotech Limited |
| Address |
Plot no.2, Phase-II, M.N. Park, Kolthur village, Shameerpet mandal, Medchal Malkajgiri dist
Hyderabad
Hyderabad
TELANGANA
500101
India |
| Phone |
402375134647 |
| Fax |
|
| Email |
jayanthi@uniquebiotech.com |
|
|
Source of Monetary or Material Support
|
| Unique Biotech Ltd
Plot no 2 Phase-II, M.N. Park Shameerpet
Hyderabad, Telangana, 500 101, India
|
|
|
Primary Sponsor
|
| Name |
Unique Biotech Limited |
| Address |
Unique Biotech Limited Plot no 2 Phase II M N Park Kolthur Village Shameerpet mandal Medchal Malkajgiri dist Hyderabad Telangana 500101 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Talekar |
Anupama foundation |
K K Estate
Modi Chawl
TJ Road
Opp Dosti Flamingo
Gate No 2, Sewri (West) Mumbai
Mumbai
MAHARASHTRA |
9323153191
mktalekar78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Probiotic capsules containing Bacillus coagulans Unique IS-2, Bacillus clausii UBBC-07- 1 Bacillus subtilis -UBBS-14, Silybum marianum-milk thistle , Choline bitartarate and Vitamin E |
One capsule twice daily for 90 days |
| Comparator Agent |
Placebo capsules which are identical to probiotic capsules without active ingredients |
One capsule twice daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Early diagnosis of NAFLD grading 1 2or 3 on abdominal ultrasound
Mild to moderate elevation of serum aminotransferase levels
Treatment naïve patients or patients not on any treatment for at least 4 weeks before inclusion
Patients with a body mass index between 25 and 40 kg per square meter
Patients with a history of controlled obesity or controlled diabetes
|
|
| ExclusionCriteria |
| Details |
Patients with an unstable metabolic condition such as weight change of more than 5 percent in the 3 months prior to inclusion
Patients with medical history of gastric bypass surgery or orthotopic liver transplant
Patients with uncontrolled diabetes mellitus type 2 at the time of screening
Patients with decompensated or severe liver disease as evidenced by one or more of the following, confirmed cirrhosis or suspicion of cirrhosis, esophageal varices, ascites, suspicion of portal hypertension, hospitalization for liver disease within 60 days of screening.
Patients with inflammatory bowel disease
Patients with diagnosed or suspected autoimmune diseases
Patients with a history of or active non liver malignancies
Patients with a significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis
Patients requiring anti-diabetic treatment or lipid lowering treatment
If patients are insulin dependent this treatment should have commenced at least 3 months prior to screening however changes in dose are permitted.
Patients with known hypersensitivity to any ingredients of the study treatment.
Patients with a positive test for human immunodeficiency virus antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
Patients with liver disease of other etiologies such as drug induced, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, haemochromatosis, alpha1 antitrypsin deficiency or Wilsons disease.
Patients with a significant history of drug or alcohol abuse
Patients who have used dietary supplements rich in omega 3 or omega 6 fatty acids, probiotics, homeopathic or herbal drugs in the 4 weeks prior to baseline.
Patients who have participated in any other clinical study with an investigational drug within 3 months
Patients who are pregnant, planning pregnancy, breastfeeding
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the change in liver fat between the two groups after 90 days of treatment and
change in serum ALT (alanine aminotransferase) from baseline to Day 90
|
Baseline and EOT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to 90 days in
AST (aspartate aminotransferase)
AST and ALT ratio
FIB 4 Index
NAFLD fibrosis score (NFS)
HOMA IR (Homeostatic model assessment Insulin Resistance)
Change in liver enzymes and lipid parameters Oxidative stress parameters ( catalase, SOD,GSHPx,iNOS, MDA and DPPH scavenging activity)
Change in glycemic parameters in fasting conditions
Change in biomarkers of inflammation (hsCRP, IL6, IL8,TNF alpha, NF kB)
Change in anthropometric parameters
 
|
Baseline and EOT |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/02/2033 |
| 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="1"
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
|
Non-Alcoholic Fatty Liver Disease (NAFLD) is a condition characterized by the accumulation of fat in the liver, which can lead to inflammation and liver damage. There have been a few studies wherein they have been found to be efficacious in the management of NAFLD . Imbalances in the gut microbiome, have been linked to the development and progression of NAFLD. Probiotics help restore a healthy balance of gut bacteria, reducing the influx of harmful substances from the intestines into the liver Moreover certain probiotics demonstrate anti-inflammatory properties.and by reducing systemic and liver-specific inflammation, probiotics may mitigate the damage caused by inflammation in the liver. In this double blind, randomized study, the efficacy of probiotic consumption for 90 days as compared to placebo will be studied in the management of NAFLD and its symptoms |