Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease
Condition: Intestinal Diseases; Ulcerative Colitis; Crohn Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been
      demonstrated in animals and humans. However, the efficacy of mangoes has not previously been
      compared with respect to mild inflammatory bowel disease. In order to justify future
      pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to
      determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step.
      Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant
      treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with
      common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the
      drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as
      helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the
      addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would
      have a significant impact on public health.
    

Detailed description: 
      Rationale and Significance : Bioactive compounds from mango are bioavailable and their
      anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy
      of mangoes has not previously been compared with respect to mild inflammatory bowel disease.
      In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical
      trials, a pilot assessment to determine efficacy in preventing or resolving IBD is a
      necessary step. Therefore, in this aim we will determine the clinical relevance of mango as
      an adjuvant treatment to conventional therapy in IBD. The effects of mango with common drug
      treatment in mild-moderate IBD will be compared to the drug-treatment alone. If mango or any
      other polyphenolic-rich food could be identified as helpful in shortening or reducing
      severity of episodes of inflammatory bowel disease, the addition of polyphenolics to
      conventional drug treatment in IBD would have a significant impact on public health.

      The clinical study will be designed in subjects with mild-moderate active Crohn's disease
      (CD) or mild to moderate ulcerative colitis (UC). This study will be carried out with up to 8
      weeks of mango treatment. Subjects with inflammatory bowel disease (IBD; CD or UC) will be
      performed at the Ertan Digestive Disease Center, Houston, TX, or Texas A&M University,
      College Station, TX. Patients may be recruited by advertisement (letters, emails, flyers,
      newspapers) or during standard of clinical care clinics: a) patients coming in for their
      regular, e.g. semi-annual or annual routine colonoscopy, b) UC or CD-related pain or
      symptoms, c) individuals presenting with diarrhoea that may be due to Crohn's disease or UC
      may also be recruited. Informed written consent will be obtained by the research personnel
      before the study begins. Approximately 90 individuals are expected to enroll in the study in
      order to obtain 60 subjects completing this study (considering screening failure and
      potential drop-outs). We expect a maximum of 90 subjects for the initial screening since many
      of these will be preselected from existing patient files.

      This study is designed to incorporate standard of care routine exams as performed within the
      division of gastroenterology. During the initial screening, the inclusion criteria of
      patients will be assessed using the clinical indices. it will be performed a screening in
      which above listed inclusion criteria and hemoglobin, and exclusion parameters and height,
      weight, calculation of BMI in kg/ (height in meters)2, albumin and C-reactive protein will be
      assessed due to the high correlation to IBD-activity (>45 mg/L). Subjects will be asked to
      give a stool sample that has to take place within 1 week before any endoscopic procedure is
      scheduled and laxatives are taken by the patients in preparation for the procedure.

      Study Treatments: Standard of clinical care + 200-400g of Mango b.i.d - t.i.d.,frozen or as
      smoothie.

      This study will be carried out as a pilot study with up to 8 weeks of mango treatment in
      addition to a list of standard of clinical care drugs. Subjects will be asked to record the
      exact amount consumed each day. Subjects who skip less than 1 day of mango consumption per
      week or less than 8 days over the entire period of 8 weeks of mango consumption will not be
      excluded from this study. Subjects will consume their regular diet but reduce the intake of
      plant-based dietary supplements which contain secondary plant compounds such as resveratrol,
      quercetin, tannins, and also reduce their carbohydrate-derived energy by the same amount
      which is supplied through their mango consumption. Patients that are not receiving the mango
      will consume their regular diet, which will be controlled for basic nutrients contained in
      the mango treatment. The mango treatment will start either on this first study day, or as
      soon as subjects can be classified within the inclusion criteria.
    

Intervention name(s): Mango polyphenolics
Intervention type(s): Drug
Intervention description(s): Frozen mango pack will be provided (200~400g per day).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment