CTRI/2019/01/016937CompletedNot Applicable
A randomized, double blind, placebo controlled, dose-response relationship study toinvestigate the efficacy of Fructo-oligosaccharides (FOS) on human gut microflorafollowing oral doses of fructo-oligosaccharides of TATA Chemicals Ltd., India in healthy,adult, human subjects.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TATA Chemicals Ltd
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •Subjects having negative urine pregnancy test at screening and on admission day 01 of basal phases (only for female subjects).
- •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).
Exclusion Criteria
- •Hypersensitivity to Fructo-oligosaccharides or Maltodextrin or related class of drugs or any of its excipients or to heparin.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to day 01 of basal phases.
- •History or presence of significant alcoholism or drug abuse.
- •History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Use of any prescribed medication during last one month or OTC medication during last two weeks prior to day 01 of basal phases.
- •Major illness within past 3 months.
- •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.
- •Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to day 01 of basal phases.
- •Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
- •Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- To measure the effect of Fructo-oligosaccharides on blood glucose, calcium and triglycerides parameters in healthy, adult, human subjects(NA)
Investigators
Study Sites (1)
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