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Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease: A Series of N-of-1 Diet Trials.

The American journal of gastroenterology
June 1, 2022
Heather C Kaplan et al. (38 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of the Specific Carbohydrate Diet (SCD) and a modified SCD (MSCD) on symptoms and inflammation in patients with inflammatory bowel disease (IBD).

Results Summary

SCD and MSCD performed similarly for most individuals, with no clinically meaningful difference in IBD symptoms or fecal calprotectin levels. Some individuals showed improvement compared to their usual diet, while others did not.

Population

Patients aged 7-18 years with IBD and active inflammation.

Effective Dosage

Not specified

Duration

8-week alternating periods (total intervention duration not specified)

Interactions

None mentioned

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
specific carbohydrate diet (SCD)
no change
IBD symptoms
patients aged 7-18 years with IBD and active inflammation
<1% probability of a clinically meaningful difference
performed similarly
#1
specific carbohydrate diet (SCD)
no change
IBD symptoms
patients aged 7-18 years with IBD and active inflammation
-0.3 (95% credible interval -1.2, 0.75)
average treatment difference
#2
specific carbohydrate diet (SCD)
no change
fecal calprotectin
patients aged 7-18 years with IBD and active inflammation
0.77, 95% credible interval 0.51, 1.10
no significant difference
#3
modified SCD (MSCD)
no change
IBD symptoms
patients aged 7-18 years with IBD and active inflammation
<1% probability of a clinically meaningful difference
performed similarly
#4
modified SCD (MSCD)
no change
IBD symptoms
patients aged 7-18 years with IBD and active inflammation
-0.3 (95% credible interval -1.2, 0.75)
average treatment difference
#5
modified SCD (MSCD)
no change
fecal calprotectin
patients aged 7-18 years with IBD and active inflammation
0.77, 95% credible interval 0.51, 1.10
no significant difference
#6
specific carbohydrate diet (SCD)
increase
symptoms
some individuals
-
had improvement
#7
specific carbohydrate diet (SCD)
increase
fecal calprotectin
some individuals
-
had improvement
#8
modified SCD (MSCD)
increase
symptoms
some individuals
-
had improvement
#9
modified SCD (MSCD)
increase
fecal calprotectin
some individuals
-
had improvement
#10
specific carbohydrate diet (SCD)
no change
symptoms
patients aged 7-18 years with IBD and active inflammation
-
did not consistently improve
#11
specific carbohydrate diet (SCD)
no change
inflammation
patients aged 7-18 years with IBD and active inflammation
-
did not consistently improve
#12
modified SCD (MSCD)
no change
symptoms
patients aged 7-18 years with IBD and active inflammation
-
did not consistently improve
#13
modified SCD (MSCD)
no change
inflammation
patients aged 7-18 years with IBD and active inflammation
-
did not consistently improve
#14
Abstract

INTRODUCTION: Evidence about specific carbohydrate diet (SCD) for inflammatory bowel disease (IBD) is limited. We conducted 54 single-subject, double-crossover N-of-1 trials comparing SCD with a modified SCD (MSCD) and comparing each with the participant's baseline, usual diet (UD). METHODS: Across 19 sites, we recruited patients aged 7-18 years with IBD and active inflammation. Following a 2-week baseline (UD), patients were randomized to 1 of 2 sequences of 4 alternating 8-week SCD and MSCD periods. Outcomes included fecal calprotectin and patient-reported symptoms. We report posterior probabilities from Bayesian models comparing diets. RESULTS: Twenty-one (39%) participants completed the trial, 9 (17%) completed a single crossover, and 24 (44%) withdrew. Withdrawal or early completion occurred commonly (lack of response [n = 11], adverse events [n = 11], and not desiring to continue [n = 6]). SCD and MSCD performed similarly for most individuals. On average, there was <1% probability of a clinically meaningful difference in IBD symptoms between SCD and MSCD. The average treatment difference was -0.3 (95% credible interval -1.2, 0.75). There was no significant difference in the ratio of fecal calprotectin geometric means comparing SCD and MSCD (0.77, 95% credible interval 0.51, 1.10). Some individuals had improvement in symptoms and fecal calprotectin compared with their UD, whereas others did not. DISCUSSION: SCD and MSCD did not consistently improve symptoms or inflammation, although some individuals may have benefited. However, there are inherent difficulties in examining dietary changes that complicate study design and ultimately conclusions regarding effectiveness.

Medical Subject Headings (MeSH)
AdolescentBayes TheoremChildColitis, UlcerativeCrohn DiseaseDietFecesHumansInflammationInflammatory Bowel DiseasesLeukocyte L1 Antigen ComplexPrecision Medicine
Study Links
Quality Scores
Safety70
Efficacy40/10
Quality75/10
Citation Metrics
Total Citations21
Citations/Year7.0
Relative Citation Ratio2.86
NIH Percentile84%
Research Impact Scores
APT Score0.95
Weight Score2.68
Normalized Score0.59
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