NCT04043000

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

28 days

First QC Date

July 10, 2019

Last Update Submit

July 8, 2020

Conditions

ProbioticsPrebiotics

Keywords

PrebioticsProbioticsMicrobiota

Outcome Measures

Primary Outcomes (4)

  • Intestinal Microflora: Bifidobacterium spp.

    Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.

    2nd, and 4th weeks

  • Intestinal Microflora: Clostridium perfringens

    Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.

    2nd, and 4th weeks

  • Intestinal Microflora: Lactobacillus spp.

    Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.

    2nd, and 4th weeks

  • Intestinal Microflora: Coliform

    Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts.

    2nd, and 4th weeks

Study Arms (2)

Super 13 Pro & Prebiotics

EXPERIMENTAL

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Dietary Supplement: Super 13 Pro & Prebiotics

Placebo

PLACEBO COMPARATOR

" The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Dietary Supplement: Super 13 Pro & Prebiotics

Interventions

Super 13 Pro & PrebioticsDIETARY_SUPPLEMENT

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

PlaceboSuper 13 Pro & Prebiotics

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, Taipei City, 112, Taiwan

Location

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • YI-HSIEN LIN

    Cheng-Hsin General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

August 2, 2019

Study Start

October 21, 2019

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

TW(1)