CryingNCT01017991
Feeding Intervention for Infants With Crying
A study testing Milk based infant formula with probiotic and Milk based infant formula in people with Crying, run by Société des Produits Nestlé (SPN) at 9 sites in United States.
Trial summary
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula. Read more about this study
- Who is it for?
- Ages 3 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Crying
- What is being tested?
- Milk based infant formula with probiotic and Milk based infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2009to Mar 2013
- 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 3 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- full term infants greater than or equal to 37 wks gestation
- 3 weeks to less than or equal to 4 months of age upon enrollment
- experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
- otherwise healthy as reported by parent/caregiver
- is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
- taking no more than one feeding of breast milk per day
Show all 9Show fewer
- having not initiated weaning foods or beverages other than infant formula or breast milk
- study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
- informed consent signed(parent/legal representative)
Who cannot join
- Chromosomal or major congenital anomalies
- known cow's milk allergy
- receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
- receiving an antibiotic or probiotic in the week prior to enrollment
- complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
- infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
- infant currently participating in another conflicting clinical study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Children's Investigational Research Program, LLC
Bentonville, Arkansas, 72712
Cook Children's Medical Center
Fort Worth, Texas, 76104
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504
Pedia Research, LLC
Newburgh, Indiana, 47630
Florida Institute for Clinical Research
Orlando, Florida, 32822
Pedia Research
Owensboro, Kentucky, 42301
Southwest Children's Research Associates, P.A.
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94118
Georgetown University Medical Center
Washington D.C., District of Columbia, 2007
About this study
Official title: Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
- Conditions
- Crying
- Being tested
- Milk based infant formula with probiotic, Milk based infant formula
- Keywords
- infants, formula, probiotic, crying
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk based infant formula with probioticOther
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
Milk based infant formulaOther
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
| Study group | Role | What they receive |
|---|---|---|
| Infant formula with probiotic | Experimental | Infant formula with probiotic for 0 to 12 months of age Receives: Other: Milk based infant formula with probiotic |
| Standard infant formula | Placebo comparator | Infant formula for 0 to 12 months of age Receives: Other: Milk based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily total crying time
Measured: 28 days
Secondary outcomes (2)
Formula intake
Measured: 4 days
Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionMar 2013
Why it stopped: The study has been terminated as a result of low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryingStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Cabana, MD,MPH, Principal investigator, University of California, San Francisco, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017991
- Sponsor's protocol ID
- 09.03.INF
- Status last verified
- Nov 2017
- First submitted
- 20 Nov 2009
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".
- ClinicalTrials.gov ID
- NCT01017991
- Acronym / sponsor ID
- 09.03.INF
- Conditions
- Crying
- Keywords
- infants, formula, probiotic, crying
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been terminated as a result of low enrollment.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Nov 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.
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula with probiotic | Experimental | Other: Milk based infant formula with probioticInfant formula with probiotic for 0 to 12 months of age |
| Standard infant formula | Placebo comparator | Other: Milk based infant formulaInfant formula for 0 to 12 months of age |
Who may qualify
- Ages
- 3 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- full term infants greater than or equal to 37 wks gestation
- 3 weeks to less than or equal to 4 months of age upon enrollment
- experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
- otherwise healthy as reported by parent/caregiver
- is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
Key exclusion criteria (7 listed)
- Chromosomal or major congenital anomalies
- known cow's milk allergy
- receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
- receiving an antibiotic or probiotic in the week prior to enrollment
- complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
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 |
|---|---|---|
| Milk based infant formula with probioticformula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration | Other | Infant formula with probiotic |
| Milk based infant formulasupplied as a powder to be constituted as commercially available formula ad libitum daily 28 days | Other | Standard infant formula |
Primary outcome
daily total crying time
Time frame: 28 days
2 secondary outcomes
Formula intake
Time frame: 4 days
Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies
Time frame: 4 days
Results and safety
The study was stopped early (reason given: The study has been terminated as a result of low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
Michael D Cabana, MD,MPH principal investigator
University of California, San Francisco, USA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk based infant formula with probiotic and Milk based infant formula in people with Crying, run by Société des Produits Nestlé (SPN) at 9 sites 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study was stopped early (reason given: The study has been terminated as a result of low enrollment.). Results are not available in the source record.
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 total crying time (time frame: 28 days). 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 17 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.