Safety of Lactobacillus Fermentum in Newborn Infants

Status Completed

Clinical Trial Summary

In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Tolerance

Clinical Trial Details

NCT number	NCT01346644
Study type	Interventional
Source	Puleva Biotech
Contact
Status	Completed
Phase	N/A
Start date	February 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05592951` - Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers	N/A
Completed	`NCT04689035` - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144	Phase 1
Recruiting	`NCT02129296` - Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study	Phase 1/Phase 2
Completed	`NCT06114524` - Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation	N/A
Active, not recruiting	`NCT06286488` - Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza	Phase 4
Completed	`NCT04529759` - Healthy Term Infants Fed Milk-Based Infant Formula	N/A
Not yet recruiting	`NCT05428748` - Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers	N/A
Completed	`NCT04499482` - Safety and Tolerability of Soy Fiber	N/A
Recruiting	`NCT01207206` - Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients	N/A
Completed	`NCT01038882` - Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy	N/A
Completed	`NCT05794100` - Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance	N/A
Completed	`NCT06187233` - The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation	N/A
Completed	`NCT04055363` - Human Milk Oligosaccharides (HMOs) Post-market Study on Infants	N/A
Recruiting	`NCT03707262` - Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor	Phase 1/Phase 2
Completed	`NCT05585762` - Buck Institute Ketone Ester RCT	N/A
Completed	`NCT02307773` - Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy	N/A
Completed	`NCT04188782` - Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
Recruiting	`NCT05527652` - Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia	N/A
Recruiting	`NCT05088694` - The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.	N/A
Completed	`NCT06034951` - Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients	N/A