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N/A Completed N=17 Treatment

Effects of a Very Low Carbohydrate Diet on Symptoms of Irritable Bowel Syndrome (IBS)

Source: ClinicalTrials.gov NCT00616200 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item. — 13 Participants

Summary

The purposes of this study are to prospectively determine the effect of a very low carbohydrate diet on quality of life and gastrointestinal symptoms in patients with diarrhea-predominant irritable bowel syndrome (IBS-D); and to determine possible physiological correlates of symptom improvement, as related to post-prandial 5-hydroxytryptamine (5-HT) release, weight loss and fiber content.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Reporting "Adequate Relief" From IBS Symptoms for the Previous Week. Adequate Relief Was a "True/False" Item.
13
SECONDARY
Impact of Very Low Carbohydrate Diet on Stool Frequency
2.6
SECONDARY
Sickness Impact Profile
2.3 .001 sig

Eligibility Criteria

Inclusion Criteria

  • Age 18-70 years old, male or female
  • Meet Rome II Criteria for IBS-D
  • Body mass index > 25 kg/m^2
  • Desire to use a very low carbohydrate diet for weight loss
  • Score of > 36 on the FBDSI
  • Ability to understand consent form
  • In stable health by screening history, physical examination performed by a study physician, laboratory tests (normal blood counts, kidney function tests, liver tests, TSH).

Exclusion Criteria

  • Age 70 years
  • History of inflammatory bowel disease
  • History of any gastrointestinal surgery that preceded the onset of IBS symptoms
  • Pregnancy or breastfeeding
  • FBDSI symptom score of ≤ 36
  • Inability to understand consent form
  • Diabetes requiring medications (must be controlled with diet and exercise alone).
  • Chronic narcotic use for any reason
  • Use of serotonin-selective reuptake inhibitors unless patient has been on a stable dose for at least 4 weeks.
  • Use of any over-the-counter or prescription weight loss medications.
  • Any chronic or unstable diseases (e.g., kidney disease, heart disease, or cancer) that may put the subject at increased risk from the intervention
  • Any of the following baseline abnormalities of laboratory tests or physical exam findings:
  • Serum creatinine > 1.5 mg/dL in men, > 1.3 mg/dL in women.
  • Liver disease (AST or ALT > 2 times the upper limit of normal or total bilirubin > 1.6mg/dL).
  • Blood pressure > 160/100 mm Hg.
  • Fasting triglycerides > 600 mg/dL.
  • Fasting serum low-density lipoprotein (LDL) cholesterol > 190 mg/dL.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00616200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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