The Specific Carbohydrate Diet And Diet Modification As Induction Therapy For Pediatric Crohn's Disease: A Randomized Diet Controlled Trial
Notes for this study:
||At week 12, ESR levels were lower in 8 of the 10 participants that completed the study. SCD: By ITT analysis ESR decreased from 28.0 ± 30.9 mm/h at enrollment to 13.0 ± 14.2 mm/h at 12 weeks. The ESR by PP analysis decreased from 15.6 ± 13.7 mm/h at enrollment to 13.0 ± 14.2 mm/h at 12 weeks. mSCD: By ITT analysis ESR decreased from 42.0 ± 26.8 mm/h at enrollment to 14.2 ± 10.2 mm/h at 12 weeks. The ESR by PP analysis decreased from 32.3 ± 10.2 mm/h at enrollment to 14.3 ± 10.2 mm/h at 12 weeks. WF: By ITT analysis ESR decreased from 21.2 ± 16.0 mm/h at enrollment to 15.5 ± 14.9 mm/h at 12 weeks. The ESR by PP analysis decreased from 27.0 ± 29.7 mm/h at enrollment to 15.5 ± 14.9 mm/h at 12 weeks. The researchers did not perform tests to determine statistical significance of any outcomes.
|Number of Subjects
||7-12, 13-17, 18-29
In this 12-week randomized diet-controlled trial, 18 patients between 7-18 years old with mild to moderate Crohn’s disease were randomized to either a SCD, modified SCD (including rice and oatmeal) or a whole foods diet that excluded wheat, corn, sugar, milk, and food additives. Prior to the randomization, all patients were put in a strict SCD for two weeks.
Funding issues for this study:
Pediatric Crohn’s Disease Activity Index (PDCAI) score, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) (an indirect measurement of inflammation), and CBC were evaluated every two weeks, and stool was collected at baseline and 12 weeks for fecal calprotectin and fecal metabolite and microbiome analysis.
Two weeks after initiation of the dietary intervention, 9 of the 14 remaining patients were in clinical remission based on PCDAI score (<10). At 4 weeks, 9 of the remaining 13 participants were in clinical remission, and at week 12, 10 out of 10 remaining patients were in remission. Rates did not differ between diets.
By week 12, CRP levels had normalized in 8 of the 8 participants who had elevated concentrations at baseline. ESR levels were lower in 8 of the 10 participants that completed the study.
Researchers utilized both Intention to Treat (ITT) and Per Protocol (PP) analysis due to the high dropout rate. Both ITT and PP analysis calculated reductions in PCDAI, CRP, and ESR in the SCD, modified SCD, and whole foods diet. Fecal calprotectin increased in the SCD and decreased in both the modified SCD and whole foods diet. The researchers did not perform tests to determine statistical significance of any outcomes.
Of the five participants whose fecal microbiomes were analyzed, alpha-diversity decreased in two participants and increased in the other three. The researchers did not perform tests to determine statistical significance of any outcomes.
One author wrote a patient handbook on nutrition in IBD called 'Nutrition in Immune Balance.'