Symbiotic supplementation effect oncritical care patients

Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190227042857N1

Enrollment

Registered

2019-03-17

Start date

2019-04-06

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

energy and macronutrient homeostasis disturbance- muscle wasting. Unspecified protein-calorie malnutrition

Interventions

Intervention 1: Intervention group: Lactocare (ZistTakhmir,Tehran, Iran) capsules 500 mg every 12h for 14 days. Intervention 2: Control group: placebo every 12h for 14 days.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adults aged 18-65 years ICU admission stable hemodynamic within 24-48 hour after admission requiring enteral nutrition(EN) via nasogastric tube (NGT) feeding not taking any kind of microbial cell preparations (pre, pro, synbiotic) providing the written consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Energy homeostasis. Timepoint: daily. Method of measurement: calorie intake- estimated calorie requirement.;Protein catabolism. Timepoint: 7, 14 days after intervention. Method of measurement: nitrogen balance.;Muscle protein turnover. Timepoint: 14 days after intervention. Method of measurement: 3MH/ Creatinine ratio in 24h urine.;Lipolysis. Timepoint: 14 days after intervention. Method of measurement: free glycerol in serum.;Dysbiosis status and luminal integrity. Timepoint: 14 days after intervention. Method of measurement: blood Endotoxin levels.	—

Measure

Time frame

Energy homeostasis. Timepoint: daily. Method of measurement: calorie intake- estimated calorie requirement.;Protein catabolism. Timepoint: 7, 14 days after intervention. Method of measurement: nitrogen balance.;Muscle protein turnover. Timepoint: 14 days after intervention. Method of measurement: 3MH/ Creatinine ratio in 24h urine.;Lipolysis. Timepoint: 14 days after intervention. Method of measurement: free glycerol in serum.;Dysbiosis status and luminal integrity. Timepoint: 14 days after intervention. Method of measurement: blood Endotoxin levels.

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Secondary

Measure	Time frame
Infectious complications incidence. Timepoint: daily. Method of measurement: incidence.;Ventilator- dependent days. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of ICU stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of hospital stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;28- Day mortality. Timepoint: 28 days after intervention. Method of measurement: mortality incidence in 28 days.	—

Measure

Time frame

Infectious complications incidence. Timepoint: daily. Method of measurement: incidence.;Ventilator- dependent days. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of ICU stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;Length of hospital stay. Timepoint: 14 days after intervention. Method of measurement: number of days.;28- Day mortality. Timepoint: 28 days after intervention. Method of measurement: mortality incidence in 28 days.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNajmeh Seifi

Mashhad University of Medical Sciences

seifin941@mums.ac.ir+98 51 3882 7033

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 28, 2026