Infectious GastroenteritisPhase 1/2NCT01130792
Probiotics for Infectious Diarrhea in Children in South India
A Phase 1/2 study testing Lactobacillus GG and Inulin in people with Infectious Gastroenteritis, run by Christian Medical College, Vellore, India at 1 site in India.
Trial summary
The overall goal of this study is to investigate whether the modulatory effects of probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance the specific immune response in children with… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Infectious Gastroenteritis
- What is being tested?
- Lactobacillus GG and Inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Jul 2011
- Phase
- Phase 1/2
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children aged 6 months to 5 years
- Diagnosis of rotaviral or cryptosporidial gastroenteritis (Rotavirus or
- Cryptosporidium EIA positive and three or more watery stools within a 24-hour period)
- No other enteric pathogen isolated from the stool at the time of enrollment
- Able to take the contents of study capsules mixed into food or milk
- No need for antibiotics for current illness
Show all 13Show fewer
- No use of LGG/other probiotics within 30 days (yogurt consumption is not an exclusion criterion)
- HIV negative
- No severe malnutrition (WAZ score < 3SD below the median)
- No evidence of active bowel leak, acute abdomen or colitis
- No history of allergy
- Parent/guardian willing to report on compliance and side effects during the study period
- Families willing to provide informed consent, participate in study and have study personnel visit their home.
Who cannot join
- Other enteric pathogens isolated from the stool at the time of enrollment
- Not willing or able to take the contents of study capsules mixed into food or milk
- Need for antibiotics for current illness
- HIV positive
- Severe malnutrition (WAZ score < 3SD below the median)
- Presence of active bowel leak, acute abdomen or colitis
Show all 9Show fewer
- History of allergy
- Parent/guardian not willing to report on compliance and side effects during the study period
- Families not willing to provide informed consent, participate in study or have study personnel visit their home.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of this study is to investigate whether the modulatory effects of probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance the specific immune response in children with cryptosporidial or rotaviral infections in South India. Rotavirus and Cryptosporidium spp. are the most important viral and parasitic causes of gastroenteritis in children in south India. Both infections can lead to severe dehydrating gastroenteritis in young children and have no specific treatment. Repeated episodes of diarrhea can result in long term deleterious effects on nutritional status, possibly due to intestinal damage. Most episodes of infectious gastroenteritis resolve without specific therapy, the mainstay of treatment being rehydration. However, oral rehydration remains under-utilized, in part due to the lack of effect on frequency of bowel movements and duration of illness. Due to the interest in simple, safe and effective measures to ameliorate the long-term effects of diarrheal illness, there is a growing appreciation for the potential of certain microorganisms to offer direct benefits to the health of a host. Probiotics are known to beneficially modulate several host functions, the most important of which are immune responses and intestinal barrier integrity. The investigators propose to build on the investigators previous collaborative efforts to conduct pilot studies to provide a mechanistic understanding of the effect of probiotic supplementation in children with rotaviral and cryptosporidial diarrhea.
Based on the established efficacy of LGG for the treatment of a variety of diarrheal diseases and the documented modulation of immune responses and strengthening of intestinal epithelial barrier function by probiotics, the investigators propose to conduct a Phase I/II double-blind randomized placebo controlled clinical trial to assess the preliminary efficacy and safety of LGG vs. placebo in the resolution of symptoms and restoration of intestinal function in children with either rotaviral or cryptosporidial diarrhea and no other detected enteric infection. Promising results in this Phase I/II study will provide preliminary data to power a future randomized trial on these critical outcomes following rotaviral or cryptosporidial infection.
- Conditions
- Infectious Gastroenteritis
- Being tested
- Lactobacillus GG, Inulin
- Keywords
- rotavirus, cryptosporidium, probiotics, intestinal function, immune response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus GGDietary supplement
10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks
InulinDietary supplement
Identical appearing capsules containing a powder resembling the LGG to be given as for intervention
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus GG | Experimental | LGG once daily for 4 weeks Receives: Dietary Supplement: Lactobacillus GG |
| Inulin | Placebo comparator | Not described Receives: Dietary Supplement: Inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG To Rotavirus VP6 Or Cryptosporidial Gp15
Measured: 4 weeks
Secondary outcomes (1)
lactulose:mannitol test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startMay 2010
- 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 Infectious GastroenteritisStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Medical College, Vellore, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Tufts Medical Center
- Responsible party
- Principal investigator, Gagandeep Kang, Christian Medical College, Vellore, India
- Investigators
- Gagandeep Kang, MD, PhD, Principal investigator, Christian Medical College, Vellore, IndiaHonorine D Ward, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130792
- Sponsor's protocol ID
- MCHPROBIO
- Other IDs
- R03HD057736, CTRI/2010/091/000339
- Status last verified
- Feb 2015
- First submitted
- 25 May 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sindhu KN, Sowmyanarayanan TV, Paul A, Babji S, Ajjampur SS, Priyadarshini S, Sarkar R, Balasubramanian KA, Wanke CA, Ward HD, Kang G. Immune response and intestinal permeability in children with acute gastroenteritis treated with Lactobacillus rhamnosus GG: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2014 Apr;58(8):1107-15. doi: 10.1093/cid/ciu065. Epub 2014 Feb 5.
PubMed 24501384
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Infectious Diarrhea in Children in South India
- ClinicalTrials.gov ID
- NCT01130792
- Acronym / sponsor ID
- MCHPROBIO
- Conditions
- Infectious Gastroenteritis
- Keywords
- rotavirus, cryptosporidium, probiotics, intestinal function, immune response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Christian Medical College, Vellore, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Tufts Medical Center
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 May 2010 (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.
The overall goal of this study is to investigate whether the modulatory effects of probiotics, which are used as food supplements (Lactobacillus GG marketed as Culturelle or yoghurt) in the gastrointestinal tract promote restoration of intestinal function and enhance the specific immune response in children with cryptosporidial or rotaviral infections in South India. Rotavirus and Cryptosporidium spp. are the most important viral and parasitic causes of gastroenteritis in children in south India. Both infections can lead to severe dehydrating gastroenteritis in young children and have no specific treatment. Repeated episodes of diarrhea can result in long term deleterious effects on nutritional status, possibly due to intestinal damage. Most episodes of infectious gastroenteritis resolve without specific therapy, the mainstay of treatment being rehydration. However, oral rehydration remains under-utilized, in part due to the lack of effect on frequency of bowel movements and duration of illness. Due to the interest in simple, safe and effective measures to ameliorate the long-term effects of diarrheal illness, there is a growing appreciation for the potential of certain microorganisms to offer direct benefits to the health of a host. Probiotics are known to beneficially modulate several host functions, the most important of which are immune responses and intestinal barrier integrity. The investigators propose to build on the investigators previous collaborative efforts to conduct pilot studies to provide a mechanistic understanding of the effect of probiotic supplementation in children with rotaviral and cryptosporidial diarrhea.
Based on the established efficacy of LGG for the treatment of a variety of diarrheal diseases and the documented modulation of immune responses and strengthening of intestinal epithelial barrier function by probiotics, the investigators propose to conduct a Phase I/II double-blind randomized placebo controlled clinical trial to assess the preliminary efficacy and safety of LGG vs. placebo in the resolution of symptoms and restoration of intestinal function in children with either rotaviral or cryptosporidial diarrhea and no other detected enteric infection. Promising results in this Phase I/II study will provide preliminary data to power a future randomized trial on these critical outcomes following rotaviral or cryptosporidial infection.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus GG | Experimental | Dietary Supplement: Lactobacillus GGLGG once daily for 4 weeks |
| Inulin | Placebo comparator | Dietary Supplement: Inulin |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male and female children aged 6 months to 5 years
- Diagnosis of rotaviral or cryptosporidial gastroenteritis (Rotavirus or
- Cryptosporidium EIA positive and three or more watery stools within a 24-hour period)
- No other enteric pathogen isolated from the stool at the time of enrollment
- Able to take the contents of study capsules mixed into food or milk
Key exclusion criteria (9 listed)
- Other enteric pathogens isolated from the stool at the time of enrollment
- Not willing or able to take the contents of study capsules mixed into food or milk
- Need for antibiotics for current illness
- HIV positive
- Severe malnutrition (WAZ score < 3SD below the median)
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 GG10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks | Dietary supplement | Lactobacillus GG |
| InulinIdentical appearing capsules containing a powder resembling the LGG to be given as for intervention | Dietary supplement | Inulin |
Primary outcome
IgG To Rotavirus VP6 Or Cryptosporidial Gp15
Time frame: 4 weeks
1 secondary outcome
lactulose:mannitol test
Time frame: 4 weeks
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 4 Feb 2015.
- Results publication: PubMed 24501384Sindhu KN, Sowmyanarayanan TV, Paul A, Babji S, Ajjampur SS, Priyadarshini S, Sarkar R, Balasubramanian KA, Wanke CA, Ward HD, Kang G. Immune response and intestinal permeability in children with acute gastroenteritis treated with Lactobacillus rhamnosus GG: a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2014 Apr;58(8):1107-15. doi: 10.1093/cid/ciu065. Epub 2014 Feb 5.
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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.
Gagandeep Kang, MD, PhD principal investigator
Christian Medical College, Vellore, India
Honorine D Ward, MD principal investigator
Tufts 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 1/2 study testing Lactobacillus GG and Inulin in people with Infectious Gastroenteritis, run by Christian Medical College, Vellore, India at 1 site in India.
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 13 inclusion and 9 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 4 Feb 2015. 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 India. 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 combined 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.
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 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?
IgG To Rotavirus VP6 Or Cryptosporidial Gp15 (time frame: 4 weeks). 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 NCT01130792, 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 4 Feb 2015.