SH-DS01 on Fecal Metagenomic Stability

NCT04598295 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019P-000274
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with constipation. 50 IBS-C or IBS-M patients will receive DS-01 (Daily Synbiotic, once daily) for 12 weeks, while 50 IBS-C or IBS-M patients will receive the placebo (once daily). Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects will also receive extensive education on use of the synbiotic.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of DS-01 Treatment vs Placebo

  measure of reported adverse events during the study period

  12 weeks

Study Arms (2)

microbial consortia (DS-01)

EXPERIMENTAL

DS-01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.

Drug: DS-01

placebo

PLACEBO COMPARATOR

Placebo capsules for DS-01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.

Drug: DS-01

Interventions

DS-01 DRUG

synbiotic

Also known as: SEED synbiotic

microbial consortia (DS-01); placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be willing and able to give informed assent/ consent for participation in the study
• Patient must be willing and able (in the PI's opinion) to comply with all study requirements.
• Patient must be a premenopausal female or male aged 18 and older.
• Patient must have a documented history of IBS that is not completely controlled by current IBS drugs.
• Patient must have a score of ≥150 on the IBS-SSS at screening.
• Patient must have no clinically relevant (in the judgment of the PI) abnormal blood laboratory levels at screening or randomization.
• The clinician will assess eligibility as per the Rome IV criteria (Recurrent abdominal pain or discomfort at least 1 day/week in the last 3 months associated with two or more of the following: Improvement with defecation. Onset associated with a change in frequency of stool).
• Patient has clinically significant unstable medical conditions other than IBS.
• Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization.
• Patient has clinically significant laboratory values (in the PI's opinion).
• Patient is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex®) or supplements (including hemp oil/extracts) within one month prior to study entry and is unwilling to abstain for the duration for the study.
• Patient has consumed any probiotic product three days prior to screening and/or is unwilling to abstain from consuming these during the study.
• Intake of antibiotics in the past 1-month (i.e. penicillin, amoxicillin, cephalexin (Keflex), erythromycin (E-Mycin), clarithromycin (Biaxin), azithromycin (Zithromax), ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin (Floxin), co-trimoxazole (Bactrim), trimethoprim (Proloprim), tetracycline (Sumycin or Panmycin), doxycycline (Vibramycin), gentamicin (Garamycin), or tobramycin (Tobrex). The supplement in the present study may have a minor interaction with these medications.
• Patient has any known or suspected hypersensitivity to pomegranate, pine, or mushrooms, or any of the excipients of the Supplement Synbiotic Product (SSP).
• Patients of child bearing potential unless willing to ensure that they use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Seed Health: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Judy Nee
• Organization: BIDMC

jnee@bidmc.harvard.edu

617-667-2193

Study Officials

• Anthony J Lembo, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: October 22, 2020
• Study Start: October 20, 2020
• Primary Completion: October 17, 2022
• Study Completion: October 26, 2022
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)