Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation

Chronic constipation and Irritable Bowel Syndrome with constipation are common
gastrointestinal disorders which negatively impact quality of life, reduce work productivity,
and account for significant direct and indirect costs. Patients with CC and IBS-C suffer with
bowel symptoms such as reduced stool frequency, hard stool consistency, straining or a
sensation of incomplete evacuation. Coupled with barriers which limit access to expensive
prescription increasing concerns regarding the long-term safety of chronically dosed
medications and, there has been an increasing demand for more "natural" solutions to a wide
range of medical conditions, including CC and IBS-C. Green kiwifruit has long been used as a
natural remedy to improve GI complaints. A growing body of literature supports the benefits
of kiwifruit for gut health and in particular, abdominal discomfort and bowel regularity. In
addition, patients are interested in dietary changes that could improve their symptoms The
investigators propose a parallel group pilot study comparing the efficacy green kiwifruit,
prunes or psyllium on abdominal and bowel related symptoms in US patients with chronic
constipation patients. The investigators plan to recruit chronic constipation patients with
or without pain. The total duration of the study will be 8 weeks (2- week baseline, 4-week
intervention, and 2-week follow-up). Eligible patients will be randomized to receive
kiwifruit (2 green kiwifruit per day, psyllium (12 g b.d./day, fiber=6g/day) or dried plums
(50 g b.d., fiber=6 gm/day) for the 4 week intervention period. It is expected that Kiwifruit
will offer greater efficacy than psyllium and prunes for abdominal and bowel symptoms in US
patients with chronic constipation. This will be the first US data addressing the efficacy of
Kiwifruit for abdominal and bowel symptoms in patients with chronic constipation.

Inclusion Criteria:

1. Presence of functional constipation according to modified ROME IV diagnostic criteria*5b
i. Must include two or more of the following:

1. Straining more than 25% of defecations

2. Lumpy or hard stools more than 25% of defecations

3. Sensation of incomplete evacuation more than 25% of defecations

4. Sensation of anorectal obstruction/blockage more than 25% of defecations

5. Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation,
support of pelvic floor)

6. Fewer than three defecations per week ii. Loose stools are rarely present without the
use of laxatives * Criteria fulfilled for the last 3 months with symptom onset at
least 6 months prior to diagnosis For the purposes of this study, patients with
abdominal pain will be included, but patients with severe pain (defined as average
daily abdominal pain score of 7 or higher during the screening period) will be
excluded. Patients with an appropriate level of GI symptoms despite taking stable
doses (>3 months) of SSRI's, tricyclics or SNRIs will be allowed to enroll.

Exclusion Criteria:

Potential participants will be excluded if they have alarm features (GI bleeding, weight
loss, unexplained iron deficiency anaemia, significant family history of colorectal cancer
or IBD), anal fissures, significant chronic diseases (cardiovascular, cancer, renal
failure, inflammatory bowel disease), previous gastrointestinal surgery (except
appendectomy or cholecystectomy), neurological diseases (e.g. multiple sclerosis, spinal
cord injury, CVA).

Patients taking opiates will not be eligible to participate. Women who are pregnant,
breastfeeding or planning a pregnancy in the 2 months post selection (trial period) will be
excluded.

As above, patients with severe IBS symptoms will be excluded (defined as average daily
abdominal pain score of 7 or higher during the screening period).