Irritable Bowel SyndromePhase 2NCT04598295
SH-DS01 on Fecal Metagenomic Stability
A Phase 2 study testing DS-01 in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- DS-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 26 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Patients who are pregnant, lactating, or planning pregnancy during the course of the study and for three months thereafter.
- Patients who have been part of a clinical trial involving any investigational product in the previous six months.
- Any other significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study.
- Patient has significantly impaired hepatic function at Visit 1 (Alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or bilirubin >2 × ULN) OR the ALT or Aspartate aminotransferase (AST) >3 × ULN and the bilirubin >2 × ULN (or international normalized ratio >1.5).
- Obesity (BMI > 30)
- Implantable device such as heart pacemaker.
- Patients unwilling to abstain from donation of blood during the study.
- History of inflammatory bowel disease.
- History of diverticulosis.
- History of cardiovascular disease.
- History of kidney/liver/serious infection.
- History of diabetes or other hormone diseases.
- History of abdominal surgery.
- Currently suffering from high blood pressure.
- Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study.
- There are plans for the patient to travel outside the USA during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of a Multi-strain Synbiotic on Fecal Metagenomic Stability, Gut Barrier Integrity, and Metabolic Output of the Gut Microbiota
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.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder that generates a significant health care burden and is the most commonly diagnosed gastrointestinal condition. Nearly 12% of all patients in the United States seek medical care in primary care practice for IBS and it accounts for 3.1 million ambulatory care visits and 5.9 million prescriptions annually.
The pathophysiology of IBS is distinctly broad compared to other gastrointestinal conditions and includes abnormalities involving motility, visceral sensation, brain-gut interaction, and distress. Though patients with IBS often have a heterogeneous symptom profile, the predominant theme is the presence of abdominal pain or discomfort that is usually relieved by defecation. Host factors such as genetics, immune function, and psychological status, as well as environmental factors such as stress, recent infection, or treatment with antibiotics, could predispose to the development of chronic IBS symptoms. Due to a myriad of contributing factors, a single cause of IBS remains enigmatic. Despite the urgent need to develop better therapies, the high range of placebo response has made clinical trials challenging, ranging from 16.0 to 71.4% with a population-weighted average of 40.2%.
Recent studies have also shown alterations in gut immune response, and a disrupted intestinal and colonic microbiome in association with IBS. The current working hypothesis is that abnormal microbiota activate mucosal innate immune responses, which increase epithelial permeability, activate nociceptive sensory pathways, and dysregulate the enteric nervous system. Targeting the microbiota and gastrointestinal tract with live organisms is a promising approach, yet previous trials have yielded limited success due to empiric strain selection, small population size, and inadequate trial design to control for a high placebo response.
This protocol aims to assess the impact of a multi-strain consortia of 24 commensal organisms across 12 species with extensive strain-specific in vivo data, assessing a range of gastrointestinal symptoms without negatively altering the naive gut microbiota. High-throughput shotgun DNA sequencing will provide opportunity for '-omics'-based analyses of the gut microbiota, which can be augmented by the metabolite profiles resulting from total microbial activity in the gut. Since many of these metabolites are bioeffector molecules acting upon the host, such analysis can provide a direct measure of the consequences of microbial activity in the gut and provide a novel integrated data set for patients with IBS. Recruited subjects will also use a smart-phone application to report day to day gastrointestinal symptoms, a patient-centric hallmark of this chronic gut condition.
Probiotics are live microorganisms with a vast array of therapeutic potential for gastrointestinal disease. Several probiotics strains have shown beneficial outcomes in constipation-predominant IBS (IBS-C) patients, especially as an adjunct to conventional treatment. However, a number of controversial issues regarding the roles of probiotics in pathogenesis of IBS-C remain to be clarified, including precise mechanism of action.
This protocol aims to assess the impact of a mix of 24-beneficial strains on individual subjects with IBS-C or IBS-M.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- DS-01
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-01Drug
Also called SEED synbiotic
synbiotic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: DS-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of DS-01 Treatment vs Placebo
measure of reported adverse events during the study period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start20 Oct 2020
- Primary completion17 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seed Health
- Responsible party
- Principal investigator, Judy Nee, Beth Israel Deaconess Medical Center
- Investigators
- Anthony J Lembo, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598295
- Sponsor's protocol ID
- 2019P-000274
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2020
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of a Multi-strain Synbiotic on Fecal Metagenomic Stability, Gut Barrier Integrity, and Metabolic Output of the Gut Microbiota
- ClinicalTrials.gov ID
- NCT04598295
- Acronym / sponsor ID
- 2019P-000274
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Seed Health
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder that generates a significant health care burden and is the most commonly diagnosed gastrointestinal condition. Nearly 12% of all patients in the United States seek medical care in primary care practice for IBS and it accounts for 3.1 million ambulatory care visits and 5.9 million prescriptions annually.
The pathophysiology of IBS is distinctly broad compared to other gastrointestinal conditions and includes abnormalities involving motility, visceral sensation, brain-gut interaction, and distress. Though patients with IBS often have a heterogeneous symptom profile, the predominant theme is the presence of abdominal pain or discomfort that is usually relieved by defecation. Host factors such as genetics, immune function, and psychological status, as well as environmental factors such as stress, recent infection, or treatment with antibiotics, could predispose to the development of chronic IBS symptoms. Due to a myriad of contributing factors, a single cause of IBS remains enigmatic. Despite the urgent need to develop better therapies, the high range of placebo response has made clinical trials challenging, ranging from 16.0 to 71.4% with a population-weighted average of 40.2%.
Recent studies have also shown alterations in gut immune response, and a disrupted intestinal and colonic microbiome in association with IBS. The current working hypothesis is that abnormal microbiota activate mucosal innate immune responses, which increase epithelial permeability, activate nociceptive sensory pathways, and dysregulate the enteric nervous system. Targeting the microbiota and gastrointestinal tract with live organisms is a promising approach, yet previous trials have yielded limited success due to empiric strain selection, small population size, and inadequate trial design to control for a high placebo response.
This protocol aims to assess the impact of a multi-strain consortia of 24 commensal organisms across 12 species with extensive strain-specific in vivo data, assessing a range of gastrointestinal symptoms without negatively altering the naive gut microbiota. High-throughput shotgun DNA sequencing will provide opportunity for '-omics'-based analyses of the gut microbiota, which can be augmented by the metabolite profiles resulting from total microbial activity in the gut. Since many of these metabolites are bioeffector molecules acting upon the host, such analysis can provide a direct measure of the consequences of microbial activity in the gut and provide a novel integrated data set for patients with IBS. Recruited subjects will also use a smart-phone application to report day to day gastrointestinal symptoms, a patient-centric hallmark of this chronic gut condition.
Probiotics are live microorganisms with a vast array of therapeutic potential for gastrointestinal disease. Several probiotics strains have shown beneficial outcomes in constipation-predominant IBS (IBS-C) patients, especially as an adjunct to conventional treatment. However, a number of controversial issues regarding the roles of probiotics in pathogenesis of IBS-C remain to be clarified, including precise mechanism of action.
This protocol aims to assess the impact of a mix of 24-beneficial strains on individual subjects with IBS-C or IBS-M.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microbial consortia (DS-01) | Experimental | Drug: DS-01DS-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. |
| placebo | Placebo comparator | Drug: DS-01Placebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DS-01Also: SEED synbioticsynbiotic | Drug | microbial consortia (DS-01), placebo |
Primary outcome
Safety and Tolerability of DS-01 Treatment vs Placebo
Time frame: 12 weeks
measure of reported adverse events during the study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J Lembo, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS-01 in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of DS-01 Treatment vs Placebo (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.