Could a PKU diet reshape the gut microbiome? a study investigates

NCT ID NCT07728032

Recruiting now Knowledge-focused Sponsor: Birmingham Women's and Children's NHS Foundation Trust Source: ClinicalTrials.gov ↗

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This observational study examines how a phenylalanine-restricted diet and PKU medications like sapropterin influence the gut microbiome in children aged 3-17. Researchers will compare stool samples from children with PKU and their healthy siblings to see if diet or drugs alter gut bacteria and metabolites. The goal is to better understand the link between PKU treatment, diet, and gastrointestinal health.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Phenylalanine-restricted diet and sapropterin dihydrochloride (Kuvan)
What this could lead to: If successful, this research could reveal how diet and medication shape the gut microbiome in PKU, potentially leading to better nutritional strategies for children with the condition.
What could go wrong: This is an observational study, not a treatment trial, so it cannot prove cause and effect. The findings may not apply to all children with PKU.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for PHENYLKETONURIA are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PHENYLKETONURIA

Contacts and locations

Locations

Birmingham Children's Hospital
RECRUITING

Birmingham, Birmingham, B4 6NH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.