NCT05520073

Brief Summary

This is a feasibility study to evaluate a decentralized (remote) clinical trial in Korea. In this study, an open-label, randomized, remote clinical trial to evaluate the effects of lactobacillus supplements on alleviating functional constipation symptoms in poor-health volunteers will be conducted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

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

August 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

August 24, 2022

Last Update Submit

March 9, 2023

Conditions

Feasibility Studies

Outcome Measures

Primary Outcomes (3)

  • Frequency of spontaneous defecation

    Frequency of spontaneous defecation

    21 days

  • Formation of stool

    According to Bristol Stool Scale

    21 days

  • Other symptoms related to defecation

    e.g. Excessive straining, bloating, anal obstruction, abdominal pain and discomfort, and manipulation of the fingers

    21 days

Other Outcomes (5)

  • The number of days on which self-records were made among the scheduled 21 days

    21 days

  • Completeness of self-record

    21 days

  • Number of times self-records were written on the due date

    21 days

  • +2 more other outcomes

Study Arms (2)

Lactobacillus and Vitamin C

EXPERIMENTAL

Lactobacillus and Vitamin C supplements daily self-administration for 14 days

Dietary Supplement: Lactobacillus plantarumDietary Supplement: Vitamin C

Vitamin C

PLACEBO COMPARATOR

Vitamin C supplements daily self-administration for 14 days

Dietary Supplement: Vitamin C

Interventions

Lactobacillus plantarumDIETARY_SUPPLEMENT

Lactobacillus product 1 pack daily

Lactobacillus and Vitamin C
Vitamin CDIETARY_SUPPLEMENT

Vitamin C tablet 1 pack daily

Lactobacillus and Vitamin CVitamin C

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged between 19 and 64 years
  • In the past 6 months, one or more of the following symptoms have been present for at least 2 weeks without having to be consecutive (based on alleviated Rome III functional constipation)
  • Excessive strain during defecation exceeds 1/4 of the total number of bowel movements
  • Lumpy or hard stool exceeds 1/4 of the total number of bowel movements
  • Feeling after defecation exceeds 1/4 of the total number of bowel movements
  • The feeling of anal obstruction during defecation exceeds 1/4 of the total number of bowel movements
  • More than 1/4 of the total number of bowel movements that require manual manipulation to help defecate
  • Less than 3 bowel movements per week
  • A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and consents before screening

You may not qualify if:

  • Those who have a clinically significant hypersensitivity reaction to lactic acid bacteria, vitamin C, or ingredients included in the drug
  • Persons with a history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or immune disease (eg, colorectal cancer, etc.)
  • Those who are pregnant or lactating
  • Those who cannot faithfully record self-recording of dosing and defecation within the clinical trial period
  • Those who are taking or expected to take lactic acid bacteria or vitamin C preparations other than health functional foods to be administered in clinical trials within the period from 2 weeks before the scheduled first dose to the last dose
  • Those who judged that the investigator is inappropriate to participate in the clinical trial due to other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 29, 2022

Study Start

September 1, 2022

Primary Completion

October 19, 2022

Study Completion

December 16, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)