Synbiotic Dietary Supplement and Gut Microbiota | NCT04097106

Studies
Synbiotic Dietary Supplement and Gut Microbiota

NCT04097106

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Dec 9, 2024Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Healthy

Interventions

Synbiotic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Actual

Primary Completion Date

Jun 27, 2022Actual

Completion Date

Jun 27, 2022Actual

First Submitted Date

Sep 18, 2019

First Submission Date that Met QC Criteria

Sep 18, 2019

First Posted Date

Sep 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2024

Last Update Posted Date

Dec 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.

Detailed Description

This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Label	Type	Description	Intervention Names
Lean BMI (19-25)			Dietary Supplement: Synbiotic
Obese BMI (30-35)			Dietary Supplement: Synbiotic

Name	Type	Description	Arm Group Labels	Other Names
Synbiotic	Dietary Supplement	Synbiotic dietary supplement in capsule form	Lean BMI (19-25) Obese BMI (30-35)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale	Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score	Baseline, Day 28, day 49, day 77
Change in microbiome stool diversity		Baseline, Day 28, day 49, day 77
Change in metabolome stool profile		Baseline, Day 28, day 49, day 77
Change in metabolome urine profile		Baseline, Day 28, day 49, day 77

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 19-25 (lean) and BMI 30-35 (obese)
Age 18-45 years old
subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)

Exclusion Criteria:

antibiotic consumption within 28 days of study initiation
diabetes
kidney disorders
history of cardiac disease and medications for cardiac disease
use of statins and antihypertensive drugs
inflammatory bowel disease
irritable bowel syndrome
history of small intestinal bacterial overgrowth
history of intestinal surgery, excluding hernia repair and appendectomy
active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
abnormal liver or kidney function as measured by routine serum chemistry testing
severe anemia or significant white blood cell or platelet abnormalities
no additional blood or blood product donations during study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Thirty two healthy volunteers, aged 18-45 years old, will be recruited for this pilot study, plan to enroll 16 subjects with a BMI 19-25 kg/m2 and 16 subjects with a BMI 30-35 kg/m2.

Sampling Method

Non-Probability Sample

ID	Term
D056692	Prebiotics
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition