The effects of enteral Royal jelly supplementation in critically ill patients

Evaluation the effect of enteral Royal jelly supplementation compared to standard enteral nutrition on gut microbiota pattern and septic complication in critically ill patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016073029127N1

Enrollment

Registered

2017-02-25

Start date

2016-08-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Supportive care critically ill patient stay in intentensive care unit. Symptoms and signs involving the digestive system and abdomen

Interventions

Intervention 1: Intervention group (1) patients are received an oral preparation containing 5000 mg RJ via tube feeding in addition to conventional therapy (500 kcal standard enteral nutrition therapy

Treatment - Drugs

Intervention group (1) patients are received an oral preparation containing 5000 mg RJ via tube feeding in addition to conventional therapy (500 kcal standard enteral nutrition therapy) per day for a

Intervention group (2) (control), patients are received only conventional therapy (standard enteral nutrition 500kcal per day) for a week.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Critically ill patients aged older than 18 years and less than 65 years; at least two signs of systemic inflammatory response syndrome (body temperature above 38 C° or less than 36 C°, heart rate more than 90 min without drug interactions , respiratory rate more than 20 in minutes, WBC lees than 4000 or more than12,000 or more than 10% immature neutrophils); at least a measure organ dysfunction syndrome (oliguria acute or urine output 2); gastric acidity(pH) less than 3.5

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Quantitative GUT microbiota pattern. Timepoint: Baseline,3 and 7 days after intervention. Method of measurement: Extraction and purification of DNA Microbiota of fecal samples or stomach juice by using Real-time PCR and Fast Start Univesal SYBR green master with Light cycler ® 96 and draw Amplification curve.;Serum Endocan Level. Timepoint: Baseline and seventh day after intervention. Method of measurement: Serum endocan levels is measured using an endocan enzyme-linked immunosorbent assay (ELISA) kit.	—

Measure

Time frame

Quantitative GUT microbiota pattern. Timepoint: Baseline,3 and 7 days after intervention. Method of measurement: Extraction and purification of DNA Microbiota of fecal samples or stomach juice by using Real-time PCR and Fast Start Univesal SYBR green master with Light cycler ® 96 and draw Amplification curve.;Serum Endocan Level. Timepoint: Baseline and seventh day after intervention. Method of measurement: Serum endocan levels is measured using an endocan enzyme-linked immunosorbent assay (ELISA) kit.

—

Secondary

Measure	Time frame
Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) II Scores. Timepoint: Baseline, 3 and 7 days after intervention. Method of measurement: Standard questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVida Kazemi

Tehran University of Medical Sciences

kazemi-v@razi.tums.ac.ir v.kazemi@yahoo.com dv.kazemi@gmail.com+98 21 6412 1202

Outcome results

None listed

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