Diarrhoeal diseases

Indications

Gastrointestinal disorders are often characterised by altered bowel activities such as diarrhoea, with or without abdominal pain and increased gas. Of all the symptoms seen in functional gastrointestinal disorders, diarrhoea is the most therapy resistant. Of general importance is information concerning diet and lifestyle. It is important to exclude organic disease when diagnosing functional diarrhoea and the diet should be well balanced as regards nutrients and fat. Diarrhoea can also de caused by an infection of the intestines by virus, bacteria, protozoa or worms. 

IBS (Irritable Bowel Syndrome) is a collective term describing a number of symptoms connected with altered bowel activity that are not necessarily of similar origin or mechanism. One group is non-painful diarrhoea. Even in this case it is important to exclude organic disease. It is not uncommon with functional gastrointestinal disorders in children and adolescents; even colon irritable occurs. 

In bloodstained diarrhoea ulcerative colitis can be assumed, but identification of Crohn’s disease is not as obvious.


Clinical studies

Treatment with SPC-Flakes® in short intestines/intestinal resections

After the encouraging results seen in animals and healthy subjects it was desirable to test the anti-diarrhoeal effects of the specially produced cereals (SPC-Flakes®) on patients with severe hypersecretion. Severe hypersecretion is experienced in patients with short intestines, often due to major intestinal resections. An open pilot study was designed under the guidance and expertise of Professor Ingvar Bosaeus at the Department of Clinical Nutrition at the Sahlgrenska University Hospital. 

The study included eight patients with varying extents of intestinal resections due to Crohn's disease. The length of their small intestine varied between 80 and 400 cm. All patients suffered from chronic diarrhoea without concurrent bowel inflammation. Six healthy controls participated. All subjects received 54 g SPC-Flakes® daily for 2 weeks. The daily dose was divided evenly over the day during at least three occasions in connection with mealtimes. Patient and control baseline diet and medications were kept unchanged. 

Plasma AF activity was determined before, during and after the treatment period. The SPC diet increased AF activity in all controls. AF activity was increased from a mean of 0,28 ± 0,37 units/ml plasma prior to treatment to 1,28 ± 0,23 AF units/ml plasma after the two week treatment period (p<0,05). Elevated levels of AF (1,28 ± 0,39) were maintained during at least four weeks after intake of the SPC diet. 

In the patients baseline values were low (0,04 ± 0,07), rising during the treatment period to a mean of 0,66 ± 0,45 units. The two patients with the longest remaining small intestine, 300 and 400 cm, achieved elevated AF levels comparable to healthy subjects, i.e. over 1 unit/ml plasma. These patients also lowered the number of daily bowel movements. Analysis showed that in the patients there was a significant correlation between the length of the remaining small intestine and AF induction (r=0.94, p<0.01). 

It was concluded that a small intestine length of at least 1 metre is needed to induce AF and to maintain the elevated levels after the treatment with AF-inducing diet. 

Lange, Bosaeus, Jennische, Johansson, Lundgren and Lönnroth, Food-induced antisecretory factor activity is correlated with small bowel length in patients with intestinal resection, APMIS, 2003; 111:985-988, view link  

AF treatment of secretory diarrhoea due to carcinoid tumours 

The pathology of diarrhoea in patients with short intestines in most likely due to multiple factors and for this reason it is possible that AF only influences the secretory component of the diarrhoea. Patients with neuroendocrine tumours may suffer from severe diarrhoea, that may be both difficult to treat, treatment resistant and persistent despite an otherwise optimal treatment regime. 

The aim of the study was to investigate if specially processed cereals, SPC-Flakes®, or Salovum® could induce AF-activity and if AF-therapy could reduce the number of bowel movements. The treatment with AF products was administered as an additive to the patients’ ongoing medical therapy. 

Eight critically ill patients were included. Six patients with the midgut carcinoid syndrome and two with metastasizing medullary thyroid carcinoma (MTC) participated. 

In an initial open part of the study all patients received Salovum® for 4 weeks. This was followed by randomisation to a double-blind crossover period with SPC-Flakes® and control cereals without AF inducing ability for 6 weeks in a dose of 1g/kg bodyweight divided into four doses daily. 

Treatment with SPC-Flakes® and Salovum®resulted in a significant reduction of daily bowel movements (Table 1) and several patients reported firmer stools.

 

Tabell 1. Number of stools during treatment

Test period Mean          n p
Baseline 5,6±2,6 7 <0,01
Salovum® 4,2±2,4 7  
Control Cereals 4,0±1,9 5 <0,05
SPC-Flakes® 2,6±1,3 5  

All patients had low levels of AF-activity in serum at baseline. During treatment with Salovum®, the mean level increased slightly. AF-activity was also significantly higher after treatment with SPC-Flakes®. In four of the five patients such AF levels in plasma were detected which has in other studies correlated well with positive treatment effects of diarrhoea. 

Although these patients had been given optimal medical therapy, an added positive effect could be seen with the addition of the AF-treatment. Treatment with Salovum® was well tolerated by all patients. The two patients with MTC and fully intact intestines responded best to SPC-diet with the highest AF levels, reaching over 1 unit/ml plasma, after completed treatment. 

The positive response to Salovum®indicates that AF protein has a local effect in the intestine, directly interacting with the receptors and its binding proteins in mucosal cells. Therapy with Salovum® may hence be a suitable treatment alternative for patients with difficulties ingesting large amounts of specially produced cereals. 

 

Laurenius, Wängberg, Lange, Jennische, Lundgren and Bosaeus, Antisecretory factor counteracts secretory diarrhoea of endocrine origin, Clinical Nutrition, 2003; 22(6):549-542, view link  


Expected treatment outcome

SPC-Flakes® is a maintenance treatment and the purpose is to stimulate the body’s own production of the AF protein. A positive therapeutic response can normally be seen after 10-15 days. The treatment should last at least one month to determine the effect of the treatment. After termination of the treatment AF levels will decline again after a few weeks. If treatment is resumed, AF levels will rise within a matter of days, indicating a biological memory for AF production. 

In the absence of a treatment effect with SPC-Flakes® this may be due to the dose being too low or that some patients’ bodies are unable to produce AF. Clinical studies demonstrate that these patients might be helped with Salovum® which is a way of supplying high doses of the AF protein without having the body produce it on its own.


Dosage

Normal dosage of AF-inducing cereals, SPC-Flakes®, is 1 g/kg bodyweight daily, divided into 2-3 occasions. When treating children the dose may need to be increased and when treating elderly it may need to be reduced. The dosage should be introduced step by step and reach full dosage after 4-6 days. The cereals can be eaten with yoghurt or boiled to a porridge without loosing the effect. 1 dl of SPC-Flakes® equals approximately 50 g.

 


Side effects, interactions and precautions

AF products have been eaten by tens of thousands of individuals and no side effects of medical nature have been reported. A few patients have experienced occasional constipation, but this discomfort can be reduced by a step-by-step introduction of the treatment. 

There are no reported interactions with concomitant medications. This is of importance as the patients should continue with their regular medical treatment. SPC-Flakes® should not replace or change the patients’ current medication. Persons with coeliac disease or gluten intolerance should not be treated with SPC-Flakes®.


Where to buy, Prescriptions

SPC-Flakes® can be bought prescription free in pharmacies or in health food shops. As of December 31, 2010, Läkemedelsverket (The Medical Products Agency) has decided to include SPC-Flakes® and Salovum® in the new revised list for food for particular nutritional use for children under 16 years of age (“Särnär”, LVFS 2010:27 ) and the cost will thus be included within the national benefit scheme for prescription drugs.
For patients 16 years of age or older, dieticians and most doctors can prescribe SPC-Flakes® as “sär-när”, foods for particular nutritional uses certified by the National Food Administration (Livsmedelsverket). The cost of the products varies between the different counties (landsting).