Common Infant Feeding ProblemsNCT01934257
The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
A study testing Marketed milk-based lactose-containing infant formula, Marketed milk-based lactose-free infant formula and Marketed soy-based lactose-free infant formula in people with Common Infant Feeding Problems, run by Mead Johnson Nutrition at 19 sites in 2 countries.
Trial summary
This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms. Read more about this study
- Who is it for?
- Ages 2 to 12 weeks
- Conditions the study is for
- Common Infant Feeding Problems
- What is being tested?
- Marketed milk-based lactose-containing infant formula, Marketed milk-based lactose-free infant formula and Marketed soy-based lactose-free infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jun 1994to Jun 1996
- Phase
- Interventional
- 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 2 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is between 2 and 12 weeks of age
- Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
- Subject has never switched to any lactose free formula
- The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
- The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
- Signed Informed Consent
Who cannot join
- Subject is in daycare for more than 4 hours per day (20 hours per week)
- Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
- The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
- Subject has acute infectious diarrhea or any other intercurrent illness
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Dr. Mark Pearlman
Aurora, California, 80011
Kentucky Pediatrics
Bardstown, Kentucky, 40004
Kids Med South
Baton Rouge, Louisiana, 70820
Chapel Hill Pediatrics
Durham, North Carolina, 27713
Welborn Clinic Peds
Evansville, Indiana, 47713
Henderson Pediatrics
Fletcher, North Carolina, 28732
Pediatric Medical Associates
Havertown, Pennsylvania, 19083
Riveria Pediatrics
Indianapolis, Indiana, 46254
Matthews Children Group
Matthews, North Carolina, 28105
Gould Medical Foundation
Modesto, California, 95355
The Pediatric Group
Princeton, New Jersey, 08540
Capital Pediatrics
Raleigh, North Carolina, 27609
Rhinelander Medical Center
Rhinelander, Wisconsin, 54501
Lewis Gale Clinic
Salem, Virginia, 24153
Memorial Medial Center Research
Savannah, Georgia, 31405
Pennridge Pediatrics
Sellersville, Pennsylvania, 18960
Pittsburgh Pediatric Research
Upper Saint Clair, Pennsylvania, 15241
Vancouver Clinic
Vancouver, Washington, 98664
About this study
This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.
- Conditions
- Common Infant Feeding Problems
- Being tested
- Marketed milk-based lactose-containing infant formula, Marketed milk-based lactose-free infant formula, Marketed soy-based lactose-free infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed milk-based lactose-containing infant formulaOther
Marketed milk-based lactose-free infant formulaOther
Marketed soy-based lactose-free infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Marketed milk-based lactose-containing infant formula | Other | Not described Receives: Other: Marketed milk-based lactose-containing infant formula |
| Marketed milk-based lactose-free infant formula | Other | Not described Receives: Other: Marketed milk-based lactose-free infant formula |
| Marketed soy-based lactose-free infant formula | Other | Not described Receives: Other: Marketed soy-based lactose-free infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Infant Temperament Questionnaire
Measured: 14 days
Secondary outcomes (3)
Infant Characteristic Questionnaire
Measured: 14 days
Maternal Efficacy Questionnaire
Measured: 14 days
Mental Health Inventory Questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJun 1994
- Primary completionJun 1996
- Study completionJun 1996
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 Common Infant Feeding ProblemsStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Rudolph, M.D., Ph.D, Study director, Mead Johnson & Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934257
- Sponsor's protocol ID
- 3332-5
- Status last verified
- Aug 2013
- First submitted
- 27 Aug 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743.
PubMed 25643020
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems
- ClinicalTrials.gov ID
- NCT01934257
- Acronym / sponsor ID
- 3332-5
- Conditions
- Common Infant Feeding Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 1994
- Primary completion
- Jun 1996 (actual)
- Study completion
- Jun 1996 (actual)
- First posted
- 4 Sep 2013 (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 clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketed milk-based lactose-containing infant formula | Other | Other: Marketed milk-based lactose-containing infant formula |
| Marketed milk-based lactose-free infant formula | Other | Other: Marketed milk-based lactose-free infant formula |
| Marketed soy-based lactose-free infant formula | Other | Other: Marketed soy-based lactose-free infant formula |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject is between 2 and 12 weeks of age
- Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
- Subject has never switched to any lactose free formula
- The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
- The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
Key exclusion criteria (4 listed)
- Subject is in daycare for more than 4 hours per day (20 hours per week)
- Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
- The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
- Subject has acute infectious diarrhea or any other intercurrent illness
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 |
|---|---|---|
| Marketed milk-based lactose-containing infant formula | Other | Marketed milk-based lactose-containing infant formula |
| Marketed milk-based lactose-free infant formula | Other | Marketed milk-based lactose-free infant formula |
| Marketed soy-based lactose-free infant formula | Other | Marketed soy-based lactose-free infant formula |
Primary outcome
Early Infant Temperament Questionnaire
Time frame: 14 days
3 secondary outcomes
Infant Characteristic Questionnaire
Time frame: 14 days
Maternal Efficacy Questionnaire
Time frame: 14 days
Mental Health Inventory Questionnaire
Time frame: 14 days
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 Sep 2013.
- Derived from this study: PubMed 25643020Sherman AL, Anderson J, Rudolph CD, Walker LS. Lactose-Free Milk or Soy-Based Formulas Do Not Improve Caregivers' Distress or Perceptions of Difficult Infant Behavior. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):119-24. doi: 10.1097/MPG.0000000000000743.
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.
Colin Rudolph, M.D., Ph.D study director
Mead Johnson & Company
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed milk-based lactose-containing infant formula, Marketed milk-based lactose-free infant formula and Marketed soy-based lactose-free infant formula in people with Common Infant Feeding Problems, run by Mead Johnson Nutrition at 19 sites in 2 countries.
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 6 inclusion and 4 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 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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.
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?
Early Infant Temperament Questionnaire (time frame: 14 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 NCT01934257, 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 Sep 2013.