Alternate Name(s):
BioGaia Protectis BABY drops
Classification:
Antidiarrheal agent; probiotic supplement
Revised Date:
November 2025
Indications:
-
Probiotic supplementation in all infants born at < 33+6 weeks gestational age, or < 1500 g
-
Prevention of severe Necrotizing Enterocolitis (NEC) and mortality in the above group
Contraindications:
- NEC
- Intestinal perforation
- Bloody stools
- Suspected or confirmed congenital immune deficiency (eg, HIV, SCIDS)
- Patients with short-gut syndrome
- Patients who are NPO
- Congenital anomalies that affect the GI tract (ex. esophageal atresia, gastroschisis, omphalocele, malrotation, intestinal atresia, Hirschsprungs, etc.)
Relative Contraindications:
- Neonatal asphyxia
- History of grade 3 NEC, intestinal perforation or recent intestinal surgery
- Medical conditions where the integrity of the digestive tract is potentially compromised (ex: suspected or proven CMPA, sepsis, hemodynamically significant PDA). Probiotics can be held at the discretion of the attending physician during an episode of sepsis or in the presence of an active PDA, until clinical stability is reached
- Acquired immunodeficiency (ex: after treatment with moderate to high dose steroids for more than 2 weeks)
- Patients with short bowel syndrome (discuss benefits vs risk with MD team)
Administration:
- Shake well for ten seconds before use. To dispense the drops, press the tube gently
-
Do not give directly from the bottle into the mouth as this may reduce the quality of the product
-
Stable 3 months after opening, when stored in a dry place at room temperature.
Dosage:
- 5 drops (0.2 mL) PO/enteral once daily.
- Per 5 drops: 100 million CFU Limosilactobacillus reuteri DSM 17938 (L. reuteri protectis)
- Start as early as possible, when neonate is clinically stable and ready to receive enteral feeds.
- Discontinue when neonate reaches 34 weeks corrected age or is transferred to a neonatal unit not using probiotics.
Side Effects:
- Usually well tolerated
- Monitor for any signs of GI intolerance
- Cases of sepsis associated with probiotic use have been reported in susceptible children, particularly those who are immunocompromised, have an active malignancy, or are born prematurely. Other possible risk factors for sepsis include central venous catheter access, impaired intestinal barrier, critical illness, short gut, administration via jejunostomy, high mucosal adhesion, and cardiac valvular disease
Notes:
- Ingredients: Sunflower oil, Limosilactobacillus reuteri DSM 17938, mono- and diglycerides of fatty acids
References:
- Bio-Gaia Product Monograph, accessed 2025
- Canadian Pediatric Society Position Statement. Using probiotics in paediatric populations. Dec 9, 2022.
- Dani C, Coviello C C, Corsini I I, Arena F, Antonelli A, Rossolini GM. Lactobacillus Sepsis and Probiotic Therapy in Newborns: Two New Cases and Literature Review. AJP Rep. 2016 Mar;6(1):e25-9.
- Alshaikh BN, Ting J, Lee S, Lemyre B, Wong J, Afifi J, Beltempo M, Shah PS; Canadian Neonatal Network Investigators. Effectiveness and Risks of Probiotics in Preterm Infants. Pediatrics. 2025 Feb 12;155(3):e2024069102.
- Lefèvre K, Leroy E, Leichnam A, Navas D, Simon L, Prot-Labarthe S. Selection of a probiotic to prevent necrotizing enterocolitis for preterm infants in a French neonatology department. Arch Pediatr. 2024 Aug;31(6):403-406.
- Söderquist Kruth S, Persad E, Rakow A. Probiotic Supplements Effect on Feeding Tolerance, Growth and Neonatal Morbidity in Extremely Preterm Infants: A Systematic Review and Meta-Analysis. Nutrients. 2025 Apr 1;17(7):1228.
- Athalye-Jape G, Rao S, Patole S. Lactobacillus reuteri DSM 17938 as a Probiotic for Preterm Neonates: A Strain-Specific Systematic Review. JPEN J Parenter Enteral Nutr. 2016 Aug;40(6):783-94.