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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months

Clinicaltrials.gov identifier NCT03936257

Recruitment Status Active, not recruiting

First Posted May 3, 2019

Last update posted July 10, 2020

Study Description

Brief summary:

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations. The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated. This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.

  • Condition or Disease:Child Development
  • Intervention/Treatment: Other: Breastfeeding
    Other: Conventional BIO Infant formula
    Other: TrueGreen BIO infant formula
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Other
  • Official Title: Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
Placebo Comparator: Breast milk
group receiving breastfeeding
Other: Breastfeeding
Infants were breastfed during 3 months minimum. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Active Comparator: infant formula conventional BIO
infant formula with conventional whey BIO
Other: Conventional BIO Infant formula
Infant were fed during 6 months with a conventional BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Active Comparator: infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
Other: TrueGreen BIO infant formula
Infant were fed during 6 months with the TrueGreen BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Outcome Measures
  • Primary Outcome Measures: 1. Evolution of growth of infants [ Time Frame: from 0 to 6 months ]
    Weight in kilograms
  • Secondary Outcome Measures: 1. Height evolution of infants [ Time Frame: from 0 to 6 months ]
    data in centimeters
  • 2. BMI evolution of infants [ Time Frame: from 0 to 6 months ]
    data in kg/m²
  • 3. Head circumference evolution of infants [ Time Frame: from 0 to 6 months ]
    data in centimeters
  • 4. Number of colic per day [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutives days every month.
  • 5. Consistency of stool [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutive days every month via Bristol scale. According to the bristol scale, seven types of stool are considered: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid The mean of stool type during 3 days is considered.
  • 6. Number of regurgitation [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutive days every month via Vandenplas scale. According to the Vandenplas scale, seven score are considered: 0 0-2 episodes/day ≥3-≤5 of small volume >5 episodes of >1 coffee spoon >5 episodes of half of the feedings in < half of the feedings Continuous regurgitations of small volumes >30 min after each feeding Regurgitation of half to complete volume of a feeding in at least half of the feedings Regurgitation of the 'complete feeding' after each feeding The mean of score during 3 days is considered.
  • 7. Number of wake up per night [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutive days every month.
  • 8. Total sleep time per day [ Time Frame: from 0 to 6 months ]
    Time in hours. Evaluation during 3 consecutive days every month.
  • 9. Plasma amino acid profile [ Time Frame: between 3rd and 4th month ]
    Methods : Liquid Chromatography and Tandem Mass Spectrometry (LC / MS / MS) List of amino acids : Taurine, Aspartic acid, Threonine, Serine, Asparagine, Glutamine acid, Glutamine, Glycine, Alanine, Citrulline, Valine, Cystine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Beta aminoisobutyric acid, Ornithine, 1-Methyl-Histidine, Histidine, Lysine, 3-methyl-Histidine, Arginine, Hydroxyproline, Proline
  • 10. Metabolomic analysis from plasma and urine samples [ Time Frame: between 3rd and 4th month ]
    Non-targeted analysis : evaluation of all small molecules in biological system, such as amino acids, sugars, alcohols, sugar phosphates, amines, fatty acids, polar lipids, hormones and vitamins, as well as specialized metabolites, such as phenolic compounds, flavonoids, monoterpenes, sesquiterpenes, polyketides, alkaloids, including xenobiotics. Methods : Liquid Chromatography and Mass Spectrometry (LC / MS)
Eligibility Criteria
  • Ages Eligible for Study: up to 21 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 0 to 3 weeks

- Child followed by a general practitioner or pediatrician

- Informed consent form signed by the legal representatives of the subject

- Commitment of legal representatives to follow the constraints generated by the study

- Insured

Exclusion Criteria:

- Infant born prematurely before 37 weeks of amenorrhea

- Child allergic to cow's milk proteins

- Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);

- Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma,
diabetes, digestive, renal, cardiac or haematological diseases);

- Incapacity for the legal representative(s) to understand or adhere to the protocol

- Subject involved in another clinical study or in an exclusion period from another
study

- Legal representatives deprived of liberty

- Legal representatives in a position to judicial protection

- Weight of the subject according to age and sex, not included between the 3rd and the
97th percentile of the WHO Child Growth Standards

- Subject height according to age and sex, not between the 3rd and the 97th percentile
of the WHO Child Growth Standards

- BMI of the subject according to age and sex, not included between the 3rd and the 97th
percentile of the WHO Child Growth Standards

- Head circumference of the subject according to age and sex, not included between the
3rd and the 97th percentile of the WHO (World Health Organization) Child Growth
Standards

- The investigator considers that the state of health or the concomitant treatments are
not compatible with the good progress of the clinical study.

Contacts and Locations
Contacts
Locations

France, Nord
NutrInvest - Institut Pasteur de Lille
Lille

Sponsors and Collaborators

Institut Pasteur de Lille

Investigators

Principal Investigator: Jean-Michel Lecerf, MD Institut Pasteur de Lille - NutrInvest

More Information
  • Responsible Party: Institut Pasteur de Lille
  • ClinicalTrials.gov Identifier: NCT03936257 History of Changes
  • Other Study ID Numbers: 2018-A00732-53
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: July 10, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No