Synbiotic Dietary Supplement and Gut Microbiota

NCT04097106 | Completed

• 1 other identifier: IRB #19-601
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Lean BMI (19-25)

Dietary Supplement: Synbiotic

Obese BMI (30-35)

Dietary Supplement: Synbiotic

Interventions

Synbiotic DIETARY_SUPPLEMENT

Synbiotic dietary supplement in capsule form

Lean BMI (19-25); Obese BMI (30-35)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Kassandra Spates-Harden

Cleveland, Ohio, 44101, United States

Location

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Gail Cresci

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Nutrition Research within Center for Human Nutrition

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: November 10, 2020
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

US (1)