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Super 13 Pro & Prebiotics on the Human Intestinal Microflora

C

Cheng-Hsin General Hospital

Status

Completed

Conditions

Prebiotics
Probiotics

Treatments

Dietary Supplement: Super 13 Pro & Prebiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT04043000
Super13-2019

Details and patient eligibility

About

This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

Full description

This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro & Prebiotics" or the control article, "The placebo without Super 13 Pro & Prebiotics" three times a day during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

Enrollment

40 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adult volunteers and willing to give voluntary written informed consent

Exclusion criteria

  • Major systemic disease
  • Pregnancy, parturient and feeding woman, or expect to be pregnant
  • Abnormal liver function
  • Abnormal renal function
  • Abnormal gastrointestinal function
  • Take medications for gastrointestinal and metabolic diseases
  • Occurrences of severe diseases within 6 months, such as stroke, myocardial infarction, major trauma and surgery • Poor compliance for study protocol

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Super 13 Pro & Prebiotics
Experimental group
Description:
"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.
Treatment:
Dietary Supplement: Super 13 Pro & Prebiotics
Placebo
Placebo Comparator group
Description:
" The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks.
Treatment:
Dietary Supplement: Super 13 Pro & Prebiotics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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