| CTRI Number |
CTRI/2012/08/002942 [Registered on: 31/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Probiotics on growth and diarrhea in children |
|
Scientific Title of Study
|
To study the effect of L. paracasei Lpc-37 or B. lactis Bi-07 supplementation for 10 months period, on diarrheal morbidity, febrile episodes, immune function, nutritional status and gut flora in apparently normal children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIN-Danisco-ver3-07-IM-10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R HEMALATHA |
| Designation |
Deputy Director/ Scientist E |
| Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
| Address |
NATIONAL INSTITUTE OF NUTRITION
Indian Council of Medical Research
Jamai osmania
Hyderabad
ANDHRA PRADESH
500007
India |
| Phone |
040-27191297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R HEMALATHA |
| Designation |
Deputy Director/ Scientist E |
| Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
| Address |
NATIONAL INSTITUTE OF NUTRITION
Indian Council of Medical Research
Jamai osmania
Hyderabad
ANDHRA PRADESH
500007
India |
| Phone |
040-27191297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R HEMALATHA |
| Designation |
Deputy Director/ Scientist E |
| Affiliation |
NATIONAL INSTITUTE OF NUTRITION |
| Address |
NATIONAL INSTITUTE OF NUTRITION
Indian Council of Medical Research
Jamai osmania
Hyderabad
ANDHRA PRADESH
500007
India |
| Phone |
040-27191297 |
| Fax |
040-27019074 |
| Email |
rhemalathanin@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Danisco Finland |
| Address |
Sokeritehtaantie 20
FIN-02460 Kantvik
Finland
tel.+358-405956353
fax+358-9-2982203
|
| Type of Sponsor |
Other [International Probiotic Company,Danisco Finland] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NATIONAL INSTITUTE OF NUTRITION |
Division of Microbiology
National Institute of Nutrition (ICMR)
Hyderabad-500007
Ph: 040-27008921 ext: 297
|
|
|
Countries of Recruitment
|
India
Finland |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Hemalatha |
Clinical Division, Natinal Institue of Nutrition (Indian Council of Medical Research) |
Tarnaka, Secunderabad
Hyderabad
ANDHRA PRADESH |
040-27191297
040-27019074
rhemalathanin@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee National Institute of Nutrition Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
childeren 2-5yrs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
B. lactis Bi-07 |
at a dose of 2-5x10 9 colony forming unit per day. for a period of 10 months. |
| Intervention |
L. paracasei Lpc-37 |
at a dose of 2-5x10 9 colony forming unit per day. for a period of 10 months. |
| Comparator Agent |
Placebo: Rice maltodextrin and silicon dioxide in vegetarian HPMC capsules |
supplement for 10 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
children aged 3-5 years, Parents willing to add a probiotic supplement or placebo each day for 10 months will be included in the study. |
|
| ExclusionCriteria |
| Details |
Children with major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism, Participation in another clinical study, Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children), past history with surgical operation of gastrointestinal tracts, Antibiotic therapy prior to enrollment, Evidence or suspicion of clinical sepsis before randomization will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Diarrhoea prevalence |
Everyday Recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of probiotics on weight gain and linear growth |
monthly weight gain |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Specific probiotic strains have been shown to improve, be able to reduce the incidence or shorten the duration of diarrhoea. Some strains have also been shown to reduce the risk for disease. One of the main targets of probiotics is the intestine, but health benefits are not limited to that. Selected probiotics have, among others, been shown to improve immune response providing a mechanism for health benefits not directly associated with the intestine. The intestine is the body’s largest immune organ and changes in the composition and/or activity of the intestinal microflora may be, in part, responsible for an observed change in immune response. The current study proposal therefore aims to investigate the influence of selected probiotics (L. paracasei Lpc-37 or B. lactis Bi-07) on the incidence and duration of acute diarrhoea, as well as immune function, nutritional status and changes in intestinal microflora. Diarrhoeal morbidity (duration and episodes –1 year) will be collected every day recall method. Use of antibiotics and febrile episodes will also be collected. Stool microflora (by PCR) and Immune markers like calprotectin and IgA will be done by ELISA. Blood sample will be obtained to assess micronutrient status (vit A, zinc, iron, calcium, Mg) and serum cytokines will be done by ELISA. Diarrheal pathogens will be investigated in children with diarrhea. Growth will be assessed by height weight and skin fold measurement. |