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Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants

Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016061128386N1
Enrollment
160
Registered
2016-07-04
Start date
2016-06-21
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

Preterm infants. Digestive system disorders of fetus and newborn

Interventions

Intervention 1: Intervention group 1: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosacch
Treatment - Drugs
Intervention group 1: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosaccharides twice a d
Intervention 2: this group will received 5 drops of milk fortified with 108 cfu/ml of Lactobacillus plantarum twice a day for two weeks
Intervention 3: this group will received 5 drops of milk fortified with 0.8 grams per dL fructooligosaccharides twice a day for two weeks
Control group: this group will received regular milk twice a day for 2 weeks.

Sponsors

Vice chancellor for research, Alborz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Infants weighing less than 2500 g or 37 week; all premature infants hospitalized in Kamali Hospital of Karaj Exclusion criteria: in the case of clinical symptoms of Sepsis (including severe lethargy, inability to feed, frequent vomiting, impaired consciousness, seizures, severe abdominal distention, laboratory findings such as positive blood culture and elevated CRP); critically ill patient for any reason.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Body Weight. Timepoint: 14 days. Method of measurement: weightening for body weight.;Fecal lactate. Timepoint: 14 days. Method of measurement: GC-MASS.;Fecal calprotectin. Timepoint: 14 days. Method of measurement: ELISA kit.;Fecal acetate. Timepoint: 14 days. Method of measurement: GC-MASS.

Secondary

MeasureTime frame
Duration of hospitalization in. Timepoint: day of discharge from hospital. Method of measurement: Counting days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboobeh Mehrabani Natanzi

Alborz University of Medical Sciences

mahboobehmehrabani@yahoo.com+98 26 3458 4919

Outcome results

None listed

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