Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial

Purpose: To evaluate the efficacy of Bacillus clausii in the treatment of pediatric constipation. Methods: A randomized, double-blind, placebo-controlled trial was conducted from January, 2021 to January, 2022 in children aged 1-5 years diagnosed with functional constipation according to Rome IV criteria. They were assigned to receive either B. clausii or placebo, once daily for four weeks. The primary out-come was treatment success (defined as ?3 spontaneous stools per week and stool consistency grade ?3 on Bristol stool chart). The secondary outcome was a comparison of stool frequency, consistency (defined by Bristol stool grade), and constipationrelated symptoms. Results: This trial enrolled 38 children (B. clausii, n=20 and placebo, n=18). At 4 weeks, no significant difference was noted in the treatment success between B. clausii and placebo groups [45% vs 56%; P=0.52). On within-group analyses, the mean (SD) of Bristol stool grade increased in both the B. clausii [1.7 (0.5) to 2.8 (1.2); P=0.003] and placebo [1.8 (0.5) to 2.8 (1.2); P=0.01] groups. Significant increases in the treatment success rate (22% to 56%, P=0.01) and mean stool frequency per week [3 (0.9) to 4.2 (1.7), P=0.01] were pronounced only in the placebo group. The frequency of painful defecation and large fecal mass were also significantly decreased in both the groups. No serious adverse events were observed. Conclusion: A 4-week course of B. clausii as the sole treatment was not more effective than a placebo for the management of functional constipation in children aged 1-5 years.

Fecal alpha1--antitrypsin in healthy and intestinal-disorder Thai children.

OBJECTIVE: Determine the normal FA1-AT level in random wet stool of Thai children using RID and NPL, and to study the correlation between RID and NPL methods for measurement of FA1-AT. MATERIAL AND METHOD: Random stool samples were collected from healthy children and intestinal-disorders patients. Alpha1-antitrypsin (FA1-AT) in wet stool samples was measured by nephelometry (NPL) and radial-immunodiffusion (RID) methods. RESULTS: Newborn infants had the highest FA1-AT level during the first day of life and declined to the same level as older children on day 3-4. Median and geometric mean of FA1-AT levels by NPL from healthy children aged 1 month-15 years was 1.23 and 1.11 mg/dL respectively. FA1-AT levels by NPL from children with severe intestinal disorders, displaying median and geometric mean at 6.77 and 12.39 mg/dL respectively, were much higher than healthy children. The RID and NPL methods showed a correlation of r = 0.87 (p < 0.01) and R2 = 0.75. CONCLUSION: Random FA1-AT assay in wet stool is a non-invasive and simple test for supporting diagnosis of protein-losing enteropathy.

Inflammatory bowel disease in Thai children: presentations and outcomes of treatment.

Inflammatory bowel disease (IBD) is characterized by idiopathic chronic intestinal inflammation, due to abnormalities in gastrointestinal immunoregulation. Pediatric IBD has been rarely reported in Thailand. We describe eight children, five girls and three boys, who were diagnosed with IBD at Ramathibodi Hospital during 1999-2005 and had a follow-up of more than one year. Four cases had Crohn's disease (CD) and four cases had ulcerative colitis (UC). The ages at diagnosis ranged from 3.5 to 15.5 years. Diagnosis of IBD was delayed for more than 12 months in five patients. Five out of eight patients had early onset of disease, before 6 years of age. The manifestations included chronic diarrhea, abdominal pain, rectal bleeding and perianal lesions. The common extraintestinal manifestations were oral ulcer, anemia, weight loss and failure to thrive. Most patients had moderate to severe diseases and ileocolic fistula developed in one patient with CD. The disease was controlled with 5-aminosalicylic acid and corticosteroid in most patients. Four patients required additional therapy with azathioprine. Infliximab was used in two patients who were chronically steroid-dependent CD, one also had persistent ileocolic fistula and both patients responded well. During the follow-up period ranging from 1.1 to 5.8 years, three patients remained growth retardation; all had early onset of disease before 6 years of age, long duration of symptoms of more than 3 years before diagnosis and had multiple relapses. It is concluded that there is an increasing number of IBD in Thai children during the recent years. Most patients had moderate to severe diseases. Early onset of disease, delay in diagnosis and treatment are responsible for more complications, particularly persistent growth impairment. Early recognition of IBD and treatment are essential for a satisfactory long-term outcome.

Modified percutaneous endoscopic gastrostomy tubes: experience in Thai children.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is a well-established alternative to open gastrostomy for providing long-term enteral nutrition. Although the commercial PEG tube is available and suitable for the procedure, its cost is relatively high for low socioeconomic people. Therefore, modified PEG tubes have been used in our hospital. OBJECTIVES: To evaluate the outcome and complications of PEG performed in children at Ramathibodi Hospital and compare the results between the commercial PEG and modified PEG tubes. METHOD: All children who had PEG performed at Ramathibodi Hospital, from January 1999 to May 2002, were included in the study. The demographic data, indications for PEG, types of PEG tube, outcomes and complications were retrospectively reviewed. The modified PEG tube was made by connecting a Malecot four-wing catheter to the previously used, re-sterilized distal part of a commercial PEG tube. RESULTS: PEG was performed on 34 children, aged 4 months to 13 years, and successfully placed in 30 children (88.2%). The commercial and modified PEG tubes were used in 20 cases and 10 cases, respectively. Early complications occurring in the first 7 days post-procedure were found in 9 cases (30%) as follow: peritonitis (1 case), peristomal wound infection (7 cases), and subcutaneous emphysema (1 case). Late complications occurring at more than 7 days post-procedure were found in 15 cases (50%) and all were minor problems. There was no difference in complication rates between the 2 types of PEG tubes. CONCLUSION: PEG is safe even in small infants. Minor complications are common but can be simply managed. The modified PEG tube is an alternative for a commercial PEG tube in an unaffordable situation.

Henoch-Schonlein purpura: clinical manifestations and long-term outcomes in Thai children.

The clinical features of 47 children with Henoch-Schonlein purpura (HSP) are presented. The most common ages at presentation ranged from 3-5 years. Duration of data collection was 60 months. The peak incidence was from December to February. The organ involvements included skin (100%), gastrointestinal tract (74.5%), renal (46.8%) and joint (42.6%). Renal involvement was detected within the first 2 months in 16 cases (72.7%) but was delayed until 6 months after diagnosis in 6 cases. No risk factors for renal involvement could be identified. The mean duration of follow-up was 2.6 years (range 1-5 years). Six out of 16 (37.5%) patients had residual renal diseases but none were end stage. Recurrent episodes of abdominal pain and skin purpura were found in a few cases during the first year. Overall prognosis of HSP is good and long-term morbidity is predominantly associated with renal involvement. Patients with initially normal urinalysis should have sequential urinary examination at least for 6 months.