Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Participants
2.2. Trial Design
2.3. Study Product
2.4. Measurements
2.5. Statistics
3. Results
3.1. Subject Characteristics
3.2. Study Product Intake
3.3. Parent-Reported Gastrointestinal Symptoms
3.4. Stool Characteristics
3.5. Growth Outcomes
3.6. Adverse Events
3.7. Infant Crying Frequency and Duration
3.8. Sleep Frequency and Duration
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Experimental Group | Control Group | Breastfed Reference | |
---|---|---|---|
n = 94 | n = 105 | n = 100 | |
Infant sex, % male/female | 50.0/50.0 | 49.5/50.5 | 50.0/50.0 |
Gestational Age (wks), Median (Q1–Q3) | 40.0 (38.0–40.0) | 39.0 (38.0–40.0) | 40.0 (39.0–41.0) |
Country, % Italy/Spain | 5.3/94.7 | 7.6/92.4 | 5.0/95.0 |
Birth weight (g), Median (Q1–Q3) | 3265 (2960–3550) | 3170 (2932–3520) | 3350 (3015–3650) |
Birth length (g), Median (Q1–Q3) | 50.0 (48.5–51.0) | 50.0 (48.0–51.0) | 50.0 (49.5–52.0) |
Mode of delivery, % vaginal/c-section 1 | 68.1/31.9 | 61.0/38.1 | 82.0/17.0 |
Order in household, % 1, 2, ≥3 | 86.2/12.8/1.1 | 81.9/15.2/2.9 | 84.0/11.1/5.0 |
Maternal age (years; mean ± SD) | 32.9 ± 5.0 | 33.2 ± 5.0 | 32.3 ± 3.8 |
Maternal BMI (kg/m2; mean ± SD) | 26.0 ± 5.8 | 25.2 ± 4.8 | 24.6 ± 5.0 |
Maternal education, % | |||
Primary School | 15 | 18 | 11 |
High School | 47 | 51 | 43 |
University | 36 | 29 | 41 |
Age at inclusion (days), Median (Q1–Q3) | 14.0 (5.0–24.0) | 15.0 (5.0–25.0) | 23.0 (9.5–27.0) |
Adverse Events | Experimental Group n = 94 | Control Group n = 104 | Breastfed Reference n = 105 | |
---|---|---|---|---|
n (%) | n (%) | p-Value | n (%) | |
Any Gastrointestinal Event | 13 (13.8) | 19 (18.3) | 0.443 | 6 (6.0) |
Abdominal Pain | 1 (1.1) | 0 (0) | 0.475 | 0 (0) |
Constipation | 6 (6.4) | 9 (8.7) | 0.600 | 3 (3.0) |
Diarrhoea | 1 (1.1) | 0 (0) | 0.475 | 0 (0) |
Flatulence | 2 (2.1) | 1 (1.0) | 0.605 | 0 (0) |
Gastroesophageal Reflux Disease | 2 (2.1) | 3 (2.9) | 1.000 | 2 (2.0) |
Infantile Colic | 1 (1.1) * | 9 (8.7) | 0.020 | 1 (1.0) |
Regurgitation | 1 (1.1) | 0 (0) | 0.475 | 1 (1.0) |
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Rodriguez-Herrera, A.; Mulder, K.; Bouritius, H.; Rubio, R.; Muñoz, A.; Agosti, M.; Lista, G.; Corvaglia, L.; Ludwig, T.; Abrahamse-Berkeveld, M.; et al. Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial. Nutrients 2019, 11, 1530. https://doi.org/10.3390/nu11071530
Rodriguez-Herrera A, Mulder K, Bouritius H, Rubio R, Muñoz A, Agosti M, Lista G, Corvaglia L, Ludwig T, Abrahamse-Berkeveld M, et al. Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial. Nutrients. 2019; 11(7):1530. https://doi.org/10.3390/nu11071530
Chicago/Turabian StyleRodriguez-Herrera, Alfonso, Kelly Mulder, Hetty Bouritius, Rocio Rubio, Antonio Muñoz, Massimo Agosti, Gianluca Lista, Luigi Corvaglia, Thomas Ludwig, Marieke Abrahamse-Berkeveld, and et al. 2019. "Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial" Nutrients 11, no. 7: 1530. https://doi.org/10.3390/nu11071530