ProbioticsPhase 4PRNCT03327051
Gastric Acid Suppression and Probiotic Colonization
A Phase 4 study testing Omeprazole and VSL #3 in people with Probiotics, run by Stanford University at 1 site in United States.
Trial summary
Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics
- What is being tested?
- Omeprazole and VSL #3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 30 Dec 2018
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers ages 18 years and ≤ 75 years.
- Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.
Who cannot join
- Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
- Previous abdominal surgery
- Currently pregnant or nursing
- Had H. Pylori Infection
- Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
- Currently consuming herbs or probiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gastric Acid Suppression on Probiotic Colonization
Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.
Read the detailed description
All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.
The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.
Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.
- Conditions
- Probiotics
- Being tested
- Omeprazole, VSL #3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Proton pump inhibitor (PPI) that suppresses gastric acid secretion
VSL #3Dietary supplement
Probiotics
PlaceboDrug
Placebo to match omeprazole
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole and VSL #3 | Active comparator | Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics Receives: Drug: Omeprazole; Dietary Supplement: VSL #3 |
| Placebo and VSL #3 | Placebo comparator | Participants will receive placebo and VSL #3 Probiotics Receives: Dietary Supplement: VSL #3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.
Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.
Measured: Week 4
Secondary outcomes (4)
Number of Participants With Symptoms Related to VSL#3 Treatment.
Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.
Measured: Week 0 through Week 4
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed.
Measured: Week 0 and Week 4
Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).
From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.
MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only.
Measured: Week 0 and Week 4
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.
MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only.
Measured: Week 0 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start20 Mar 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Habtezion, Stanford University
- Investigators
- Aida Habtezion, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327051
- Sponsor's protocol ID
- 41681
- Acronym
- PR
- Status last verified
- Feb 2020
- First submitted
- 26 Oct 2017
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh G, Haileselassie Y, Briscoe L, Bai L, Patel A, Sanjines E, Hendler S, Singh PK, Garud NR, Limketkai BN, Habtezion A. The effect of gastric acid suppression on probiotic colonization in a double blinded randomized clinical trial. Clin Nutr ESPEN. 2022 Feb;47:70-77. doi: 10.1016/j.clnesp.2021.11.005. Epub 2021 Nov 10.
PubMed 35063245
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gastric Acid Suppression on Probiotic Colonization
- ClinicalTrials.gov ID
- NCT03327051
- Acronym / sponsor ID
- PR / 41681
- Conditions
- Probiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probiotics are over-the-counter dietary products with microorganisms that are generally consumed for health benefit. However, the durability of these microorganisms is unclear, particularly when they pass through the highly acidic environment of the stomach. We will test the colonization of these microorganisms among individuals who consume probiotics with and without acid suppression therapy.
Detailed description
All activities will be related to research. Participants will be randomized to receive either over-the-counter acid suppression medication or placebo from weeks -2 through week 4. All participants will receive VSL #3 (over-the-counter probiotic) from weeks 0 through 4. Survey data, serum, and stool samples will be collected at weeks -2, 0, and 4.
The intervention medication and probiotics have a very low side effect profile and are available over the counter. All data collection methods are non-invasive.
Elucidation of the effects of acid suppression on probiotic colonization will allow us to better understand the utility of probiotics use by individuals on acid suppression medications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole and VSL #3 | Active comparator | Drug: Omeprazole, Dietary Supplement: VSL #3Participants will receive a proton pump inhibitor (Omeprazole) and VSL #3 Probiotics |
| Placebo and VSL #3 | Placebo comparator | Dietary Supplement: VSL #3, Drug: PlaceboParticipants will receive placebo and VSL #3 Probiotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers ages 18 years and ≤ 75 years.
- Able to visit the study Doctor's office 3 times, answer 3 questionnaires, and provide stools and blood samples.
Key exclusion criteria (6 listed)
- Gastric cancer, Barrett's esophagus cancer, any gastrointestinal condition, or soy or gluten sensitivity
- Previous abdominal surgery
- Currently pregnant or nursing
- Had H. Pylori Infection
- Diagnosed with any chronic medical condition other than hypertension or hyperlipidemia
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 |
|---|---|---|
| OmeprazoleProton pump inhibitor (PPI) that suppresses gastric acid secretion | Drug | Omeprazole and VSL #3 |
| VSL #3Probiotics | Dietary supplement | Omeprazole and VSL #3, Placebo and VSL #3 |
| PlaceboPlacebo to match omeprazole | Drug | Placebo and VSL #3 |
Primary outcome
Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.
Time frame: Week 4
Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.
4 secondary outcomes
Number of Participants With Symptoms Related to VSL#3 Treatment.
Time frame: Week 0 through Week 4
Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration
Time frame: Week 0 and Week 4
Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).
Time frame: Week 0 and Week 4
Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).
Time frame: Week 0 and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35063245Singh G, Haileselassie Y, Briscoe L, Bai L, Patel A, Sanjines E, Hendler S, Singh PK, Garud NR, Limketkai BN, Habtezion A. The effect of gastric acid suppression on probiotic colonization in a double blinded randomized clinical trial. Clin Nutr ESPEN. 2022 Feb;47:70-77. doi: 10.1016/j.clnesp.2021.11.005. Epub 2021 Nov 10.
- Individual participant dataSharing planned: No
Related trials for Probiotics
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
RecruitingPhase 1
The Gut - PRO Study
Alzheimer Disease
Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
RecruitingPhase 2
Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection
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.
Aida Habtezion, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole and VSL #3 in people with Probiotics, run by Stanford University 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 2 inclusion and 6 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 11 Mar 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Jan 2020). 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?
Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4. (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327051, which also lists 1 linked publication.
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 11 Mar 2020.