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An intergenerational prebiotic approach to establishment of a healthy colonic microbiome in infants.

An intergenerational prebiotic approach to establishment of a healthy colonic microbiome in infants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000450213
Enrollment
39
Registered
2018-03-28
Start date
2017-06-05
Completion date
2017-10-09
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Resistant starch is the amount of total starch consumed which escapes digestion in the small intestine, reaching the large intestine where it becomes a substrate for resident microbes, producing short chain fatty acids (SCFA). This increase in SCFA results in an environment in which beneficial microbes prosper, ultimately leading to a healthier microbiome in the large intestine and therefore acting as a ‘prebiotic’. Our hypothesis is that feeding this prebiotic starch (in the form of high amylose maize starch or’ HAMS’) to young women of reproductive age and to infants will beneficially alter their faecal microbiomes, which in the long term potentially leads to improved intestinal function, growth, and cognition. To test this we first need to know if consuming resistant starch results in changes in pH and SCFA in the large intestine as measured by faecal samples, a proxy for this internal environment.

Interventions

Resistant starch as High Amylose Maize Starch (HAMS) was fed to two groups of participants for 6 weeks as follows: Women of child-bearing age Milkshakes containing 25 grams of HAMS were chosen as the most appropriate food ‘vehicle.’ The 25 gram dosage was based on the literature (Hu et al. 2016; Le Leu et al. 2009; Muir et al. 1998). HAMS was purchased from Ingredion Australia (http://apac.ingredion.com/) and shipped to India where it was then measured into 25 gram portions prior to the study f

Resistant starch as High Amylose Maize Starch (HAMS) was fed to two groups of participants for 6 weeks as follows: Women of child-bearing age Milkshakes containing 25 grams of HAMS were chosen as the most appropriate food ‘vehicle.’ The 25 gram dosage was based on the literature (Hu et al. 2016; Le Leu et al. 2009; Muir et al. 1998). HAMS was purchased from Ingredion Australia (http://apac.ingredion.com/) and shipped to India where it was then measured into 25 gram portions prior to the study for ease of preparation by staff. Milkshakes were prepared and delivered to participants by study staff on a daily basis. Bottles were labelled with the participant ID. Participants were asked to consume the milkshake in its entirety each day for the 42 days of the study and did so under the observation of study staff. Stool samples were collected at baseline and thereafter at 2 weekly intervals until 2 weeks post-intervention. Early-weaning infants The food vehicle options comprised those foods that participants were eating in their usual diet. 10 grams of HAMS was added to the preferred daily food of each participant at the point of consumption. Stool samples were collected at baseline and thereafter at 2 weekly intervals until 2 weeks post-intervention.

Sponsors

SRM Institutes for Medical Science
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
6 Months to 25 Years
Healthy volunteers
Yes

Inclusion criteria

Women: aged 18 to 25 years (inclusive) Infants: aged 6-7 months of age (inclusive)

Exclusion criteria

Women: • Presence of any chronic disease • Currently pregnant or intending to have a child in the next two months Infants: • Presence of any chronic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026