Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204591594284 Date of Approval: 06/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Impact of Probiotics on Gut Microbiota and Non-Alcoholic Fatty Liver Disease (NAFLD) Progression
Official scientific title The Impact of Probiotics on Gut Microbiota and Non-Alcoholic Fatty Liver Disease (NAFLD) Progression: Controlled Attenuated Parameter (CAP) Elastography Study
Brief summary describing the background and objectives of the trial The gut–liver axis has many implications in non-alcoholic fatty liver disease onset as the major contributor of intestinal dysbiosis, possibly due to the tight anatomic-functional crosstalk of the two organs. Gut microbiota have an important role in intestinal barrier function and reversal of leaky gut. Probiotics may restore intestinal barrier integrity and contribute to the recovery of hepatic functions as well as alleviating inflammatory and fibrogenic processes. We aimed to evaluate the impact of probiotics on gut microbiota and non-alcoholic fatty liver disease progression.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/10/2018
Actual trial start date 28/02/2019
Anticipated date of last follow up 30/08/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group NASH The intervention groups received probiotics in the form of Lacteol forte sachets™ (RAMEDA) composed of (10 billion Lactobacillus delbruekii and Lactobacillus fermentum/ sachet) taken once daily orally 30 minutes before meal time for six months (NASH patients received VIT E supplementation). SIX months The intervention groups received probiotics in the form of Lacteol forte sachets™ (RAMEDA) composed of (10 billion Lactobacillus delbruekii and Lactobacillus fermentum/ sachet) taken once daily orally 30 minutes before meal time for six months (NASH patients received VIT E supplementation). 30
Control Group group II VIT E supplementation 800MG Six months VIT E supplementation 800MG 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with bright liver having steatosis detected by (VCTE-CAP) elastography The exclusion criteria were patients with a history of significant alcohol consumption more than 30 g/day in men and > 20 g/day in women, patients with positive hepatitis B or C virus markers, and patients with hepatic focal lesions. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/10/2018 Tanta ethical committee
Ethics Committee Address
Street address City Postal code Country
Elgheish streat Tanta 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to evaluate the effect of probiotics on non-alcoholic fatty liver disease progression and the decrease in fibrosis and normalization of the enzymes at 3 months then 6 months
Secondary Outcome adverse effects of probiotics at 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
single Elgeish streat Tanta 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amal Dewidar Elgeshstreat Tanta 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Elgeshstreat Tanta 35127 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Dewidar AmaldDewidar@tanta.med.edu.eg 01557836338 V.l
City Postal code Country Position/Affiliation
Elmahala elkobra 35127 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Fryal Elkalla fryalelkalla@med.tanta.edu.eg 0123456780 Teba streat
City Postal code Country Position/Affiliation
Tanta 35127 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Rehab Badawi rehab.elsheshtawy@med.tanta.edu.eg 01014860506 Elmoraa streat
City Postal code Country Position/Affiliation
Elmahala elkobra 35127 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de identification could be available including study protocol and results Immediately following publication. No end date. Anyone who wishes to access the data can do for any purpose. Study Protocol Immediately following publication. No end date Anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information