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The effect of probiotics on the treatment of malnutrition in adults

Effects of a Combination Probiotic on Anthropometric Indicators, Gut Permeability, Inflammation, and Oxidative Stress Status of Underweight Adults: A Study Protocol for a Triple-Blind Randomized Controlled Clinical Trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230310057667N1
Enrollment
100
Registered
2023-03-30
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Adult malnutrition. Mild protein-calorie malnutrition

Interventions

Intervention 1: Intervention group: Receive weight gain diet (500 kcal more than daily requirement), multivitamin and probiotic supplement (containing 109 CFU/capsule, lactobacillus with maltodextrin,

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Healthy Adults 18 to 65 years old Body mass index less than 18.5 kg/m2 Consent to participate in the study by signing the informed consent form Provision of written informed consent

Exclusion criteria

Exclusion criteria: Smoking or alcohol consumption Pregnancy or lactation History of antibiotics or probiotic supplements or consumption of foods containing probiotics within three months before commencement of this study. Regular consumption of foods containing probiotics History of chronic diseases such as inflammatory bowel disease (IBD), liver disease, kidney disease, cancer, diabetes, or irritable bowel syndrome Taking drugs that affect appetite or body weight

Design outcomes

Primary

MeasureTime frame
Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Formula (weight/height squared).

Secondary

MeasureTime frame
Waist circumference and hip circumference. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Tape meter.;Medial arm circumference (MUAC). Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Tape meter.;Complete blood count (CBC-RDW). Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Biochemical analysis of blood sample.;Body composition (fat mass, fat-free mass, lean body mass, skeletal muscle index, total body water content, basal metabolic rate). Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Bioelectric Impedance Analysis (BIA) device.;Phase angle. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Bioelectric Impedance Analysis (BIA) device.;Appetite. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Visual analog scales (VAS).;Dietary intake. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: 3-day 24-hour recall.;Blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Digital pressure gauge.;Stool consistency status. Timepoint: At the beginning of the study (before the start of the intervention) and 8 weeks after the start of probiotic consumption. Method of measurement: Bristol stool chart.;Body weight. Timepoi

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Hatami

Mashhad University of Medical Sciences

hatamia991@mums.ac.ir+98 51 3882 7034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 4, 2026