| CTRI Number |
CTRI/2019/01/016937 [Registered on: 07/01/2019] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A randomized, double blind, placebo controlled dose-response relationship study in healthy, adult, human subjects. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled, dose-response relationship study to
investigate the efficacy of Fructo-oligosaccharides (FOS) on human gut microflora
following oral doses of fructo-oligosaccharides of TATA Chemicals Ltd., India in healthy,
adult, human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 14-VIN-413, Version No. 01, Dated 22 Dec 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ronak Prajapati |
| Designation |
Pricipal Investigator |
| Affiliation |
Veeda Clinical Research Pvt Ltd |
| Address |
Veeda Clinical Research Pvt Ltd Shivalik Plaza Near IIM Ambawadi Ahmedabad
Shivalik Plaza Near IIM Ambawadi Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
|
| Fax |
|
| Email |
Ronak.Prajapati@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan SHah |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research Pvt |
| Address |
Veeda Clinical Research Pvt Ltd Shivalik Plaza Near IIM Ambawadi Ahmedabad
Shivalik Plaza Near IIM Ambawadi Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-30013000 |
| Fax |
079-30013000 |
| Email |
gunjanshah79@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ronak Prjapati |
| Designation |
Incharge Clinical Department |
| Affiliation |
Veeda Clinical Research Pvt |
| Address |
Veeda Clinical Research Pvt Ltd Shivalik Plaza Near IIM Ambawadi Ahmedabad
Shivalik Plaza Near IIM Ambawadi Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-30013000 |
| Fax |
079-30013000 |
| Email |
ronak.prajapati@veedacr.com |
|
|
Source of Monetary or Material Support
|
| TATA Chemicals Ltd.
Innovation Centre
Survey No 315, Hissa No 1-14
Ambedveth (V), Paud road,
Mulshi, Pune - 412111
Telephone no: 020-6654 9707 |
|
|
Primary Sponsor
|
| Name |
TATA Chemicals Ltd |
| Address |
Innovation Centre
Survey No 315 Hissa No 1-14
Ambedveth (V) Paud road
Mulshi Pune - 412111
Telephone no: 020-6654 9707 |
| Type of Sponsor |
Other [Chemical Industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Veeda Clinical Research Pvt Ltd |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad – 380 015, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ronak Prajapati |
Veeda Clinical Research Pvt Ltd |
2nd Floor, Clinical Research department,Shivalik Plaza A
Near IIM Ambawadi
Ahmadabad
GUJARAT |
917930013000
Ronak.Prajapati@veedacr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anveshhan Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fructo-oligosaccharides (FOS) |
Test treatment 01 (T1): Once Daily Oral Once Fructo-oligosaccharides powder at a dose of 2.5 g/d
Test treatment 02 (T2): Once Daily Oral Fructo-oligosaccharides powder at a dose of 5.0 g/d
Test treatment 03 (T3):Once Daily Oral Fructo-oligosaccharides powder at a dose of 10.0 g/d
Placebo treatment (P):Once Daily OralPowder containing Maltodextrin
Total duration for the study will be of at least 7 months. |
| Comparator Agent |
T1, t2 and T3 - Fructo-oligosaccharides powder |
placebo-Powder containing Maltodextrin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18 and 55 years (both inclusive).
2. Subjects weight within normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 45 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations (Annexure IIIa) within the clinically acceptable reference range (Annexure IIIb).
4. Subjects having clinically accepted 12-lead electrocardiogram (ECG).
5. Subjects having clinically accepted chest X-Ray (PA view).
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.
9. Subjects having negative urine pregnancy test at screening and on admission day 01 of basal phases (only for female subjects).
10. For Female Subjects:
Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
Postmenopausal for at least 1 year, or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
|
|
| ExclusionCriteria |
| Details |
1.
Hypersensitivity to Fructo-oligosaccharides or Maltodextrin or related class of drugs or any of its excipients or to heparin.
2.
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3.
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to day 01 of basal phases.
4.
History or presence of significant alcoholism or drug abuse.
5.
History or presence of significant smoking (more than 10 cigarettes or beedis/day).
6.
History or presence of asthma, urticaria or other significant allergic reactions.
7.
History or presence of significant gastric and/or duodenal ulceration.
8.
History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
9.
History or presence of cancer.
10.
Difficulty with donating blood.
11.
Use of any prescribed medication during last one month or OTC medication during last two weeks prior to day 01 of basal phases.
12.
Major illness within past 3 months.
13.
Volunteer who have donated blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at screening (more than 100 ml within 30 days; more than 200 ml within 60 days) prior to day 01 of basal phases of the study or have received a known investigational drug within five elimination half life of the administered drug prior to the first dose of the study drug.
14.
Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to day 01 of basal phases.
15.
Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.
16.
History or presence of significant easy bruising or bleeding.
17.
History or presence of significant recent trauma.
18.
Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
19.
Female subjects who are currently breast feeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the bifidogenic properties of Fructo-oligosaccharides (FOS) administered at different dose level of 2.5 g/d, 5.0 g/d and 10 g/d in the diet and dose response relationship of the Fructo-oligosaccharides (FOS) at doses ranging from 2.5 to 10 g/d in comparison with a placebo controlled treatment arm in healthy, adult, human subjects |
A total of ten (10) stool samples will be collected during the study on day 1, 30, 60, 75, 90, 120, 150, 165, 180 and 210 over a period of 7 months from each subject. Preferably morning stool sample will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the effect of Fructo-oligosaccharides on blood glucose, calcium and triglycerides parameters in healthy, adult, human subjects |
NA |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2015 |
| Date of Study Completion (India) |
26/10/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No Publication is done Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
80 healthy, adult, male and female human subjects were enrolled in the study. 77 subjects completed the study as per protocol. The investigational products were well tolerated by the subjects. Seven subjects (Subject No. 35, 57, 17, 36, 66, 59 and 58) reported adverse event after administration of investigational product. Not clinically significant or serious adverse event occurred during the conduct of the study |