Ulcerative ColitisPhase 2NCT00895336
Lactobacillus GG in Pediatric Ulcerative Colitis (UC)
A Phase 2 study testing Lactobacillus GG in people with Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Abstract: Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Lactobacillus GG
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2012
- Phase
- Phase 2
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to provide written informed consent (and if applicable, Assent) and comply with study assessments for the full duration of the study;
- Enrolled without regard to gender, race, ethnicity;
- Age > 5 years to < 18 years;
- Diagnosis of Ulcerative Colitis (UC);
- Remission or mild disease activity defined by a PUCAI <34;
- Subjects taking stable doses (defined as 30 days) of all UC medications including AZA/6-MP, methotrexate, mesalamine, or infliximab at entry will be included;
- Willing to use birth control during study participation for females of child-bearing potential, as determined by investigator.
Who cannot join
- Current use, or use in the last 3 months, of probiotic preparations, not including yogurt;
- Known history of HIV or other known immunocompromised disease;
- Any central vascular line;
- Concomitant administration of an antibiotic, and must be off antibiotics for at least one month prior to enrollment;
- Cardiac valvular disease;
- Any other condition requiring current hospitalization for treatment;
Show all 12Show fewer
- Current use of prednisone or budesonide;
- Diagnosis of Crohn's disease or indeterminate colitis;
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential;
- Females of child-bearing potential who are unwilling to use birth control during study participation;
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated;
- Participation in another simultaneous clinical trial involving a drug or biological other than participation in the Pediatric IBD Registry and/or the Pediatric IBD Network for Research and Improvement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis
Abstract:
Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative Colitis (UC). Studies using probiotic administration to modify the flora for either induction or maintenance of remission in IBD have had mixed results. Whether probiotics may exert an anti-inflammatory effect in IBD is not known. The investigators hypothesize that daily administration of a probiotic, Lactobacillus GG, for four weeks will reduce objective markers of mucosal inflammation in pediatric UC patients. The investigators will enroll 20 UC patients in remission or with mild disease activity. These patients will have a one month period of observation without intervention. They will then receive Lactobacillus GG (Culturelle), 1010 CFU by mouth twice a day for four weeks (28 days). At baseline and Day 28, and at day 56 clinical disease activity will be measured using the Pediatric UC Activity Index (PUCAI), a blood sample for determination of circulating granulocyte pSTAT3+ activation will be obtained, and a stool sample for determination of fecal calprotectin will be obtained. In addition, =the investigators will sample subject saliva to determine salivary glycan phenotype as a surrogate marker of changes of mucosal glycan expression in response to probiotic administration. The investigators anticipate that both circulating granulocyte pSTAT3+ activation and fecal calprotectin, as established biomarkers of colonic inflammation, will be reduced in subjects who receive Lactobacillus GG. Completion of the proposed studies will determine whether Lactobacillus GG reduces mucosal inflammation in pediatric UC, and will provide information to design a larger randomized trial.
The investigators' study design is novel in that it is the first probiotic study in children with UC and it will measure outcomes utilizing the biomarkers fecal calprotectin and pSTAT3+ circulating granulocytes.
- Conditions
- Ulcerative Colitis
- Being tested
- Lactobacillus GG
- Keywords
- Pediatric Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative, Pediatric ulcerative colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GGBiological
Also called Culturelle
1 capsule taken twice daily for a minimum of 28 days to a maximum of 35 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be a reduction in the fecal calprotectin level following the receipt of study agent.
Measured: after dosing 28 - 35 days with LGG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: IND for this study remained on clinical hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Lee Denson, M.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895336
- Sponsor's protocol ID
- 2009-0443
- Status last verified
- Feb 2017
- First submitted
- 27 Apr 2009
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00895336
- Acronym / sponsor ID
- 2009-0443
- Conditions
- Ulcerative Colitis
- Keywords
- Pediatric Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND for this study remained on clinical hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 8 May 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.
Abstract:
Current evidence suggests that the enteric flora is the primary trigger for chronic mucosal inflammation in the Inflammatory Bowel Diseases (IBD), Crohn's Disease (CD) and Ulcerative Colitis (UC). Studies using probiotic administration to modify the flora for either induction or maintenance of remission in IBD have had mixed results. Whether probiotics may exert an anti-inflammatory effect in IBD is not known. The investigators hypothesize that daily administration of a probiotic, Lactobacillus GG, for four weeks will reduce objective markers of mucosal inflammation in pediatric UC patients. The investigators will enroll 20 UC patients in remission or with mild disease activity. These patients will have a one month period of observation without intervention. They will then receive Lactobacillus GG (Culturelle), 1010 CFU by mouth twice a day for four weeks (28 days). At baseline and Day 28, and at day 56 clinical disease activity will be measured using the Pediatric UC Activity Index (PUCAI), a blood sample for determination of circulating granulocyte pSTAT3+ activation will be obtained, and a stool sample for determination of fecal calprotectin will be obtained. In addition, =the investigators will sample subject saliva to determine salivary glycan phenotype as a surrogate marker of changes of mucosal glycan expression in response to probiotic administration. The investigators anticipate that both circulating granulocyte pSTAT3+ activation and fecal calprotectin, as established biomarkers of colonic inflammation, will be reduced in subjects who receive Lactobacillus GG. Completion of the proposed studies will determine whether Lactobacillus GG reduces mucosal inflammation in pediatric UC, and will provide information to design a larger randomized trial.
The investigators' study design is novel in that it is the first probiotic study in children with UC and it will measure outcomes utilizing the biomarkers fecal calprotectin and pSTAT3+ circulating granulocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ability to provide written informed consent (and if applicable, Assent) and comply with study assessments for the full duration of the study;
- Enrolled without regard to gender, race, ethnicity;
- Age > 5 years to < 18 years;
- Diagnosis of Ulcerative Colitis (UC);
- Remission or mild disease activity defined by a PUCAI <34;
Key exclusion criteria (12 listed)
- Current use, or use in the last 3 months, of probiotic preparations, not including yogurt;
- Known history of HIV or other known immunocompromised disease;
- Any central vascular line;
- Concomitant administration of an antibiotic, and must be off antibiotics for at least one month prior to enrollment;
- Cardiac valvular disease;
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 |
|---|---|---|
| Lactobacillus GGAlso: Culturelle1 capsule taken twice daily for a minimum of 28 days to a maximum of 35 days. | Biological | – |
Primary outcome
The primary endpoint will be a reduction in the fecal calprotectin level following the receipt of study agent.
Time frame: after dosing 28 - 35 days with LGG
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
Related trials for Ulcerative Colitis
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
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.
Lee Denson, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
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 Lactobacillus GG in people with Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati 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 12 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: withdrawn, as of the sponsor's last update on 7 Feb 2017. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint will be a reduction in the fecal calprotectin level following the receipt of study agent. (time frame: after dosing 28 - 35 days with LGG). 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 7 Feb 2017.