ColicLGGNCT01279265

Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic

A study testing Nutramigen with Enflora and Nutramigen A+ in people with Colic and Inflammation, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 weeks to 3 monthsHealthy volunteers can take part
Conditions the study is for: Colic, Inflammation
What is being tested?: Nutramigen with Enflora and Nutramigen A+
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Jan 2013
Phase: Interventional
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 3 weeks to 3 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

Who cannot join

chronic lung disease,
diarrhea (stools that take the shape of a container > 5x daily)
fever

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic

This study will compare 2 currently marketed formulas in healthy full term babies: Nutramigen A+ (a hypoallergenic formula) and Nutramigen-Enflora (hypoallergenic formula with Lactobacillus GG (LGG)) during 3 months of formula feeding. The investigators' aims are to compare 3 outcomes in these babies: (1) normal baby crying time; (2) the composition of intestinal microbiota (bacteria in the stool); and (3) a lab test which measures the number of white blood cells in the large intestine (fecal calprotectin). The investigators predict that LGG supplementation (Nutramigen-Enflora) will facilitate its establishment as an important component of the neonatal intestinal microbial community and reduce fecal calprotectin.

Conditions: Colic, Inflammation
Being tested: Nutramigen with Enflora, Nutramigen A+
Keywords: Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary, Breath Hydrogen, Clinical Design
Medical subject headings: Colic, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutramigen with EnfloraDietary supplement
Hypoallergenic formula with probiotic - Lactobacillus GG
Nutramigen A+Dietary supplement
Also called (Nutramigen Lipil)
Hypoallergenic formula without lactobacillus

Study groups in NCT01279265
Study group	Role	What they receive
Nutramigen Lipil with Enflora	Active comparator	Formula with probiotics (Lactobaccillus Rhamnosus GG) Receives: Dietary Supplement: Nutramigen with Enflora
Nutramigen A+	Placebo comparator	Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG) Receives: Dietary Supplement: Nutramigen A+

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Average Crying and Fussing Duration According to Barr Diary Records
The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.
Measured: 90 days

Secondary outcomes (2)

Fecal Microbiota
Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.
Measured: 90 days
Fecal Calprotectin
Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jan 2013

First posted19 Jan 2011 (estimated)
Study startSep 2011
Primary completionJan 2013
Study completionJan 2013

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 (2)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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279265
Sponsor's protocol ID: HSC-MS-10-0048
Acronym: LGG
Status last verified: Oct 2015
First submitted: 12 Jan 2011
Last updated: 11 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22.
PubMed 19628216
Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
PubMed 30177353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Crying, Intestinal Microbiota, and Intestinal Inflammation in Infants With Colic
ClinicalTrials.gov ID: NCT01279265
Acronym / sponsor ID: LGG / HSC-MS-10-0048
Conditions: Colic, Inflammation
Keywords: Lactobacillus, Probiotic, Crying time, Fecal microbiota, Calprotectin, Colic, Infant Crying, Barr Diary
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Mead Johnson Nutrition
Study start: Sep 2011
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Posted 11 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Nutramigen Lipil with Enflora	Active comparator	Dietary Supplement: Nutramigen with EnfloraFormula with probiotics (Lactobaccillus Rhamnosus GG)
Nutramigen A+	Placebo comparator	Dietary Supplement: Nutramigen A+Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)

Who may qualify

Ages: 3 weeks to 3 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Sixty healthy full-term colicky infants (gestational age 32 wks to 41 wks)

Key exclusion criteria (3 listed)

chronic lung disease,
diarrhea (stools that take the shape of a container > 5x daily)
fever

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
Nutramigen with EnfloraHypoallergenic formula with probiotic - Lactobacillus GG	Dietary supplement	Nutramigen Lipil with Enflora
Nutramigen A+Also: (Nutramigen Lipil)Hypoallergenic formula without lactobacillus	Dietary supplement	Nutramigen A+

Primary outcome

Daily Average Crying and Fussing Duration According to Barr Diary Records
Time frame: 90 days
The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.

2 secondary outcomes

Fecal Microbiota
Time frame: 90 days
Fecal Calprotectin
Time frame: 90 days

Results and safety

Results posted to the registry on 11 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nutramigen Lipil With Enflora	13	9
Nutramigen A+	17	11

Primary outcome: Daily Average Crying and Fussing Duration According to Barr Diary Records

Time frame: 90 days. Mean (95% Confidence Interval). Unit: minutes

Measure	Nutramigen Lipil With Enflora n = 9	Nutramigen A+ n = 11
Value	111 (65 to 157)	133 (60 to 205)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 days (3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nutramigen Lipil With Enflora	0 of 9 (0%)	0 of 9 (0%)	Not reported
Nutramigen A+	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): 75% of eligible babies either declined to enter the study or dropped out.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19628216Rhoads JM, Fatheree NY, Norori J, Liu Y, Lucke JF, Tyson JE, Ferris MJ. Altered fecal microflora and increased fecal calprotectin in infants with colic. J Pediatr. 2009 Dec;155(6):823-828.e1. doi: 10.1016/j.jpeds.2009.05.012. Epub 2009 Jul 22.
Derived from this study: PubMed 30177353Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.

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Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
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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.

J. M 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 study testing Nutramigen with Enflora and Nutramigen A+ in people with Colic and Inflammation, 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 1 inclusion and 3 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 Nov 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 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2015). 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?

Daily Average Crying and Fussing Duration According to Barr Diary Records (time frame: 90 days). 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 NCT01279265, which also lists 2 linked publications.

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 Nov 2015.