ColicPhase 1NCT00922727
Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
A Phase 1 study testing L. reuteri and Sunflower Oil in people with Colic and Gastrointestinal Tract Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day for a total of 60 doses. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Colic, Gastrointestinal Tract Infections
- What is being tested?
- L. reuteri and Sunflower Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adults (18 - 60 years old)
- No other recognized illness
Who cannot join
- Pregnancy or breastfeeding
- Patient taking immunosuppressive medications, including oral corticosteroids
- Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Abnormal lab test results
- Gastrointestinal related diseases and surgeries
- Patients with an allergy to antibiotics
Show all 16Show fewer
- Presence of fever or a pre-existing adverse event monitored in the study
- No more than two study participants in one household
- Use of probiotics in the last 90 days
- Diarrheal illness within the past 30 days
- Recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks)
- Current use of oral laxatives
- Chronic alcohol use or more than 1 drink per day
- Subjects with implanted prosthetic devices including prosthetic heart valves
- Known sensitivity to sunflower oil or products containing linolenic/oleic acids
- Will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the 6-month period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults
This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.
Read the detailed description
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.
- Conditions
- Colic, Gastrointestinal Tract Infections
- Being tested
- L. reuteri, Sunflower Oil
- Keywords
- L. reuteri, Cytokines, Toll like receptors, Healthy Adults, Probiotics
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteriBiological
Also called BioGaia Drops
The oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops.
Sunflower OilBiological
Also called Placebo
As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops.
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Active comparator | Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. Receives: Biological: L. reuteri |
| Sunflower Oil | Placebo comparator | Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia. Receives: Biological: Sunflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.
Measured: 8/1/2009 - 7/1/2009
Secondary outcomes (1)
Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells.
Measured: 4/1/2009-7/1/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColicStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, J. Marc Rhoads, The University of Texas Health Science Center, Houston
- Investigators
- J. Marc Rhoads, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922727
- Sponsor's protocol ID
- HS-MSC-08-0266
- Other IDs
- R21AT003519-01A2, U01AT003519
- Status last verified
- Jan 2018
- First submitted
- 15 Jun 2009
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mangalat N, Liu Y, Fatheree NY, Ferris MJ, Van Arsdall MR, Chen Z, Rahbar MH, Gleason WA, Norori J, Tran DQ, Rhoads JM. Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.
PubMed 22970150
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults
- ClinicalTrials.gov ID
- NCT00922727
- Acronym / sponsor ID
- HS-MSC-08-0266
- Conditions
- Colic, Gastrointestinal Tract Infections
- Keywords
- L. reuteri, Cytokines, Toll like receptors, Healthy Adults, Probiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.
Detailed description
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.
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 |
|---|---|---|
| L. reuteri | Active comparator | Biological: L. reuteriLactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. |
| Sunflower Oil | Placebo comparator | Biological: Sunflower OilPlacebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Adults (18 - 60 years old)
- No other recognized illness
Key exclusion criteria (16 listed)
- Pregnancy or breastfeeding
- Patient taking immunosuppressive medications, including oral corticosteroids
- Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Abnormal lab test results
- Gastrointestinal related diseases and surgeries
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 |
|---|---|---|
| L. reuteriAlso: BioGaia DropsThe oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops. | Biological | L. reuteri |
| Sunflower OilAlso: PlaceboAs suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. | Biological | Sunflower Oil |
Primary outcome
Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.
Time frame: 8/1/2009 - 7/1/2009
1 secondary outcome
Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells.
Time frame: 4/1/2009-7/1/2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Results publication: PubMed 22970150Mangalat N, Liu Y, Fatheree NY, Ferris MJ, Van Arsdall MR, Chen Z, Rahbar MH, Gleason WA, Norori J, Tran DQ, Rhoads JM. Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.
Related trials for Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
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.
J. Marc Rhoads, M.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L. reuteri and Sunflower Oil in people with Colic and Gastrointestinal Tract Infections, run by The University of Texas Health Science Center, Houston 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 16 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 25 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated. (time frame: 8/1/2009 - 7/1/2009). 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 NCT00922727, 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 25 Jan 2018.