The Effect of Alpha-lactalbumin on Microbiota Composition

To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.

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Key information

Conditions

Alpha-lactalbumin Dysbiosis Microbiota Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Polispecialistico Giovanni Paolo I°

Viterbo, Rome, 01100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

condition of dysbiosis

Exclusion criteria

antibiotic treatment within 1 month
probiotic or prebiotic treatments
concomitant inflammatory intestinal diseases
pregnancy
neoplastic diseases
allergy to milk protein (Alpha-lactalbumin)
substance abuse

Treatment and study plan

Alpha-Lactalbumin

Dietary Supplement

Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days

Primary outcomes

Improvement of microbiota composition

Time frame: Change from baseline microbiota composition to 30 days of treatment

Determination of bacterial biodiversity by metagenomics approach

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jan 6, 2023
Registry last updated: Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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