The Trial of a New Infant Formula in Healthy Term Chinese Infants

Healthy Infants Clinical Trial

— HexaHMO  

Official title:

Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053112
• Other study ID #: JLB-CH002
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2023
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Junlebao Dairy Group Co., Ltd.
• Contact: Yiping XUN, Ph.D.
• Phone: +86-15630401019
• Email: xunyiping[@]jlbry.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent indicating that the infant's both parents/legally acceptable representative(s) (LAR(s)), as per local regulation, have been informed of all pertinent aspects of the study.

2. Parents/LAR(s) of infants have reached the legal age of majority in China.

3. Parents/LAR(s) of infants are willing and able to comply with scheduled visits, and the requirements of the study protocol and can be contacted directly by telephone throughout the study.

4. At enrollment visit, infant post-natal age is =14 days (date of birth = day 0)

5. Healthy term infant (=37 weeks of gestation).

6. Infant birth weight was =2500g and =4000g.

7. For formula-fed groups, infant is exclusively consuming and tolerating a cow' s milk infant formula since at least 3 days prior to enrollment. Its parents/LAR(s) have independently elected not to breastfeed.

8. For the breastfed REFERENCE group, infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and its parents/LAR(s) have made the decision to continue exclusively breastfeeding until at least 4 months of age.

Exclusion Criteria:

1. Conditions requiring infant feedings other than those specified in the protocol.

2. Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).

• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).

• Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infant inappropriate for entry into the study. Of note, infants who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in infancy and do not require some of the exclusionary medication mentioned below can be enrolled.

3. Presently receiving or have received prior to enrollment any medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.

4. Currently participating or having participated in another interventional clinical trial since birth.

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• New infant formula with 6 HMOs blend
Infants are fed with HMO formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.
• Standard infant formula without 6 HMOs blend
Infants are fed with standard formula from the date of enrollment to the age of 6 months, exclusive formula feeding until the age of 4 months.

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha
China	Shanghai Public Health Clinical Center affiliated to Fudan University	Shanghai
China	Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	The Third People's Hospital affiliated to Hebei Medical University	Shijiazhuang

Sponsors (2)

Lead Sponsor	Collaborator
Junlebao Dairy Group Co., Ltd.	Merieux NutriSciences (China)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Faecal markers of immune health and gut inflammation and barrier integrity at baseline, the age of 4 months, 6 months and 12 months respectively	calprotectin, a-1-antitrypsin, lipocalin-2, claudin-3, cathelicidin, a-defensin and ß-defensin assessed by ELISA	until the age of 12 months
Other	Illnesses and infections based on standard AE/SAE reporting		until the age of 12 months
Other	Medication use based on standard AE/SAE reporting		until the age of 12 months
Other	Breastmilk composition assessed by HPLC at baseline, the age of 42 days, 4 months and 6 months respectively		until the age of 6 months
Primary	Weight gain (g/day) between enrollment and the age of 4 months		until the age of 4 months
Secondary	Fecal secretory IgA (mg/g dry feces) at the age of 4 months corrected for baseline values		until the age of 4 months
Secondary	Weight (g) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Body length (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Body length gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Head circumference (cm) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Head circumference gain (cm/week) at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Weight-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Length-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Weight-for-length WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Head-circumference-for-age WHO growth standard z-scores at the ages of 42 days, 3 months, 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Weight gain (g/day) between enrollment and the age of 6 months and 12 months respectively		until the age of 12 months
Secondary	Stool pattern, GI symptoms and GI-related behaviors recorded in the retrospective 1-day questionnaire at baseline and in the prospective 3-day GI Symptom and Behavior Diary for 3 days prior to the age of 42 days, 3 months, 4 months, 6 months		until the age of 6 months
Secondary	Fecal microbiome composition, diversity, community type assessed by NGS sequencing at baseline, the age of 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Fecal acetic acid, propionic acid, butyric acid, isobutyric acid, valeric acid, isovaleric acid, and total short chain fatty acids at baseline, the age of 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Fecal pH at baseline, the age of 4 months, 6 months and 12 months respectively		until the age of 12 months
Secondary	Fecal secretory IgA (mg/g dry feces) at the age of 6 months corrected for baseline values		until the age of 6 months