This paper examines the use of probiotic therapy — particularly Lactobacillus reuteri — as an alternative treatment for infantile colic, a behavioral condition affecting up to 28% of infants in the first three months of life. The paper describes the disease process and its uncertain etiology, outlines standard dosing conventions for probiotics, and reviews multiple clinical studies demonstrating significant reductions in crying time among colicky breastfed infants treated with L. reuteri compared to simethicone or placebo. It also addresses reported adverse reactions, potential drug interactions, the theoretical basis for probiotic efficacy, and patient education considerations regarding FDA regulation of dietary supplements.
This study guide is drawn from PaperDue's library of 130,000+ paper examples across 47 subjects.
The paper demonstrates effective use of evidence synthesis: rather than relying on a single study, it sequences multiple studies (Savino et al. 2004, Savino et al. 2007, Romano et al. 2010) to build a cumulative case, showing how findings across different populations and methodologies converge on a consistent conclusion about L. reuteri's efficacy for infantile colic.
The paper opens with a clinical description of infantile colic and its uncertain etiology, then transitions to the intervention (probiotic therapy), reviews supporting clinical evidence, addresses safety and drug interactions, explains the theoretical mechanism, and closes with evidence-based practice recommendations and a patient education section. This disease-to-treatment structure is standard for clinical or pharmacological papers and guides the reader logically from problem to proposed solution.
Infantile colic is a very common problem within the first three months of life. It affects as many as three percent to twenty-eight percent of infants and is characterized by a behavioral condition distinguished by spastic, extreme, inconsolable crying without a particular reason (Savino, Pelle, Palumeri, Oggero, & Miniero, 2007). Colic is often described as crying and tremendous irritability in babies. The fits of inconsolable crying often occur in the evening, though many babies do not follow a predictable pattern. The crying and fussiness can go on for hours at a time, followed by periods when the infant appears completely content. Colic is extremely common and affects approximately one in four infants. The cause of the irritability is not completely understood but may involve underdevelopment of the infant's nervous system, sleep disturbances, sensitivity to surroundings, and sensory overstimulation. Only a small portion of colicky infants will actually be affected by specific medical conditions such as gastroesophageal reflux or food allergies. These alternative possibilities should be discussed with a healthcare provider before a diagnosis of colic is made (Infantile Colic, n.d.).
Colic typically follows the rule of threes: crying begins by three weeks of age, lasts for at least three hours a day, and occurs for at least three days a week. The colicky infant will begin crying as loudly as possible, appearing to be in obvious pain, often turning red in the face, kicking the legs, arching the back, and passing gas. Occasionally, feeding will momentarily stop the crying, only for it to resume afterward. Despite these symptoms, colicky babies continue to gain weight and grow normally (Infantile Colic, n.d.).
The cause of colic is not known. Researchers have explored a variety of possibilities, including allergies, lactose intolerance, an undeveloped digestive system, maternal anxiety, and differences in the way an infant is fed or comforted. Thus far, it remains unclear why some infants develop colic and others do not (Colic, 2010).
There is currently no specific treatment, but much can be done to reduce the impact on parents of this exhausting condition. Frequently, the baby's formula is changed to a hypoallergenic variety. Some mothers adjust their own diets, eliminating gas-producing foods or dairy products. If acid reflux is suspected, antacids may be tried and continued if they provide clear benefit. In most cases, what is required is a great deal of patience. Parents and other family members should take turns caring for the baby. Infant massage, calming music, and swaddling can all help in caring for a colicky baby (Colic, 2010).
Currently there are no standardized dosing recommendations for probiotics. The general guidelines followed by compounding pharmacists and healthcare providers suggest one billion to ten billion CFUs for infants and ten billion to twenty billion CFUs for older children and adults. Probiotics should be taken with food or with milk in the case of infants, as this helps shield against stomach acids, allowing more of the active probiotic components to pass through the stomach for absorption in the intestines (Intro to Probiotic Therapy, 2010).
Lactobacillus is a type of bacteria with many different strains. These are known as friendly bacteria that normally reside in the digestive, urinary, and genital systems without causing illness. Lactobacillus is also found in some fermented foods such as yogurt and in dietary supplements. It is used for treating and preventing diarrhea, including infectious forms such as rotaviral diarrhea in children and traveler's diarrhea. It is also used to prevent and treat antibiotic-associated diarrhea and, more recently, has begun to be used to treat infantile colic (Lactobacillus, 2010).
In a study by Romano et al. (2010), the effect of L. reuteri supplementation on the frequency and severity of recurrent abdominal pain in children was examined. This multi-centre clinical trial was conducted in patients recruited from children referred to the Pediatric Departments of the Universities of Messina, Palermo, and Catania, as well as the Pediatric Unit of Vittoria, Sicily. Potentially eligible subjects kept a diary recording symptoms, the frequency of daily pain, drug use, and any additional symptoms during the four weeks prior to possible study inclusion. Patients between 6 and 16 years of age with recurrent abdominal pain as defined by the Rome III criteria were included. In accordance with those criteria, the researchers defined recurrent abdominal pain as an intermittent combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. All parents were fully informed about the aims of the study, and informed consent was obtained from at least one parent prior to inclusion. Exclusion criteria included organic disease — established by medical history, complete blood count, urinalysis, stool examination for occult blood and parasites, abdominal ultrasound, and screening for celiac disease — as well as other chronic disease and growth failure.
Modulation of the gut microbial flora has become an attractive treatment option in recurrent abdominal pain using specific defined probiotic strains of Lactobacillus. The known safety profile of true probiotic bacteria, along with the growing understanding of probiotic mechanisms, can support clinicians in using probiotics in children with recurrent abdominal pain as an alternative or adjunct when conventional therapy has not been effective (Romano et al., 2010).
In a study by Savino, Cresi, Pautasso, Palumeri, Tullio, Roana, Silvestro, and Oggero (2004), it was found that lactobacilli were less common in colicky infants than in control groups. The low frequency of colonization with micro-aerophilic lactobacilli observed in colicky infants is largely consistent with earlier observations and supports the hypothesis that colic is frequently associated with food allergy and reflects an interaction between altered gut microflora and the development of oral tolerance or atopy.
In a study by Savino, Pelle, Palumeri, Oggero, and Miniero (2007), supplementation with L. reuteri was found to significantly improve colicky symptoms in breastfed infants compared to standard treatment with simethicone, within seven days of therapy. The response rate for the L. reuteri treatment group was 95%, while only 7% of infants responded to simethicone. The beneficial effects of probiotic supplementation in this study are thought to be linked to the restoration of intestinal lactobacilli balance in infants with colic. Recent research has shown that modulation of microflora with probiotics, including L. reuteri, can shift the intestinal microbial ecology from potentially harmful flora toward flora that is beneficial to the host, reducing the risk of gastrointestinal infections and allergic disease. In particular, early probiotic supplementation aims to provide safe yet adequate microbial stimulation for the immature immune system, and L. reuteri has been administered to newborns in efforts to reinforce positive outcomes associated with lactobacillus colonization.
There is a complex relationship between the intestinal immune system and commensal flora. It has been shown that luminal endogenous flora can initiate key processes of bacteria-induced innate and adaptive host responses through the activation of toll-like receptors and nucleotide oligomerization domain receptors located on intestinal epithelial cells. In animal models, cytokines can trigger a hyper-reflex response of the enteric neuromusculature through neuroimmune and myoimmune interactions. Additionally, inappropriate interactions between the microflora and toll-like receptors are thought to affect gut motor function, leading to abdominal dysmotility and colicky behavior. In particular, L. reuteri and other commensal bacteria influence dendritic cell activity, type 1/type 2 T-helper cell balance, and cytokine production in the intestinal epithelium. Recent research has also shown that L. reuteri has inhibitory effects on visceral pain, modulating the inflammation-associated visceral hypersensitivity response through a more direct action on enteric nerves (Savino et al., 2007).
In one study, a group of Italian researchers examined twenty-five healthy infants randomly assigned to receive drops of Lactobacillus reuteri and compared them to twenty-one healthy infants randomly assigned to receive placebo drops. All infants were diagnosed with colic, born full-term at a healthy gestational weight, had no history of gastrointestinal illness, were breastfed rather than formula-fed, and had not received any other probiotic supplements during the week before the study. The infants' mothers were also instructed to avoid cow's milk in their own diets throughout the study (Probiotic may soothe colicky babies, 2010).
Crying was measured in minutes per day. At the start of the study, crying times in the L. reuteri group and the placebo group were comparable. Over a three-week period, infants received either placebo drops or five drops of Lactobacillus reuteri mixed with sunflower oil once daily, thirty minutes before morning feeding. Investigators also collected stool samples from the infants to measure bacterial levels. After three weeks, crying decreased in both groups, but the L. reuteri infants showed the greater reduction — from a mean of 370 minutes of crying per day at baseline to 35 minutes at the end of the study. The placebo group's mean crying time decreased from 300 minutes per day to 90 minutes per day. Stool analysis also showed a significant decrease in the presence of E. coli among infants who received the L. reuteri drops. Researchers suggested that infants in the placebo group may have improved due to the reduction of cow's milk in the mothers' diets (Probiotic may soothe colicky babies, 2010).
Overall, the findings support the idea that Lactobacillus reuteri may help reduce colic symptoms by improving gut motility and function, which in turn could decrease gas in the gastrointestinal tract and reduce abdominal pain and cramping. At the same time, Lactobacillus reuteri appears to reduce levels of harmful E. coli (Probiotic may soothe colicky babies, 2010).
Probiotics are important not only for healthy digestion, but also as a first line of immune protection. They also help maintain the body so that seasonal, environmental, or food allergies do not develop. The side effects associated with probiotic therapy may include:
Lactobacillus reuteri, one of the few endogenous Lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data has confirmed its safety following long-term dietary supplementation in newborns. Positive effects of this probiotic on intestinal conditions such as constipation and diarrhea, protection from infection, and the ability to modulate immune responses have also been demonstrated (Savino et al., 2007).
Microbial stimulation during the first months of life shapes immune responses, influencing the development of tolerance to ubiquitous allergens. The intestinal microflora may play a particularly important role in this process, as it is the primary external driving force in the maturation of the immune system after birth. Researchers have tested the hypothesis that modulating the gut microflora of colicky infants through the oral administration of probiotics would reduce the crying associated with infantile colic (Savino et al., 2007).
Recent research has suggested that colic may be linked to an immature immune system struggling with bacterial imbalance in the gastrointestinal tract, and that high levels of E. coli bacteria in particular may contribute to colic symptoms. Some researchers have investigated whether symptoms could be reduced using probiotic therapy — that is, healthy bacteria to re-establish bacterial equilibrium in the gut. Research findings support the idea that Lactobacillus reuteri may help decrease colic symptoms by improving gut motility and function, which could lessen gas in the gastrointestinal tract and reduce abdominal pain and cramping. At the same time, Lactobacillus reuteri appears to decrease levels of harmful E. coli (Woznicki, 2010).
You’re 67% through this paper. Sign up to read the remaining 4 sections.
Sign Up Now — Instant Access Already a member? Log inAlways verify citation format against your institution’s current style guide requirements.